The Gap Jobs in Usa

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• Federal and state employment compliance requirements
  
• Internal HR policies, plan documents, and programs
  
• Common core HR processes (hire, job changes, leave, time eligibility, employee data)
  

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• Documented, repeatable compliance programs with clear ownership
  
• Audit-ready evidence for regulated workforce requirements
  
• Clear visibility into system-enforced vs manual controls
  
• Reduced reliance on institutional knowledge
  
• Clean handoff to internal HR Compliance governance
  

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• Re-establish and make process improvement recommendations for Federal and state compliance workplace obligations (EEO-1 reporting, VETS-4212, Affirmative Action plan requirements, Federal and state labor law posters, I-9, etc.) for a complex, matrixed enterprise with multiple HCM systems
  
• Develop a compliance requirements inventory (federal, state, and local)
  
• Define ownership, evidence standards, review cadence, and escalation paths
  
• Revise related process documentation (e.g., SOPs, desktop procedures, flow diagrams)
  
• Create a compliance calendar with deadlines, triggers, and dependencies
  

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• Map regulated requirements and internal policies to HCM system controls
  
• Identify where system configurations are fully or partially automated and where excessive reliance on manual processes or workarounds
  
• Document policy-system-process alignment for core HR domains (total rewards, staffing, job data, employee classifications, policy adherence, etc.)
  
• Establish audit-ready documentation for system-based controls
  

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• Design lightweight system control validation approaches (sampling, evidence review)
  
• Define configuration attestation expectations for system owners
  
• Identify and document control gaps and risk exposures
  
• Support internal audit readiness (without performing audit activities)
  

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• Integrate compliance programs into a committee-style operating model
  
• Establish a sustainable handoff model to internal HR Compliance ownership including a review schedule and RACI
  

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• Legal interpretation of employment law
  
• Policy drafting or legal language development
  
• Payroll processing or payroll system controls
  
• Employee relations case management
  
• Training delivery or change management execution
  

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• 5+ years in HR compliance, workforce compliance, or employment-related governance
  
• Hands-on experience with:
  
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  • Employer filings (EEO-1, VETS 4212, CA Pay Filing)
    
  • Federal employer requirements
    
  • Multi-state employment compliance operations
    
  
  
  
• Demonstrated experience building or re-establishing compliance programs, not just running tasks
  
• Experience working with HRIS/HCM systems in a compliance or controls capacity
  
• Experience in regulated environments (healthcare, insurance, financial services, or similar)
  

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• Strong understanding of:
  
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  • Federal workforce compliance requirements
    
  • State employment law variability and tracking
    
  • HR data dependencies for regulatory filings
    
  
  
  
• Ability to translate regulatory requirements into process and system controls
  
• Comfortable documenting gaps, risks, and manual dependencies
  
• Strong documentation and process design skills
  
• Able to work cross-functionally with HR, Legal, IT, Internal Audit, and Compliance
  

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• Oracle HCM, Peoplesoft or similar enterprise HCM experience
  
• Prior partnership with Internal Audit or Compliance functions
  
• Experience supporting system implementations or post-go-live stabilization
  

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• Employment Compliance Manager (former or contract)
  
• HR Compliance Program Manager
  
• Workforce Compliance Lead
  
• HRIS Controls / Governance Specialist
  
• Internal Audit professional with HR compliance exposure
  

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• ER specialists
  
• Payroll managers
  
• Policy analysts without regulatory filing experience
  
• Change management consultants
  

Before applying please note that this position requires US citizenship due to government related contracts

Job Title: Project Coordinator / Program Operations Specialist

Location: Chicago, IL

Pay Rate: $75 to $90.81 per hour

Duration: 12 months (Possible extension)

Job Description:

The Project Coordinator serves as the primary point of contact for one or more projects, ensuring effective coordination, communication, and execution of all project-related activities. This role supports early-stage project planning, interval coordination, deliverables management, and ongoing project support to ensure milestones are completed on time. The position requires strong analytical skills, cross-functional collaboration, and a proactive approach to identifying process improvements and resolving project risks or gaps.

Key Responsibilities:

Project Coordination and Execution:

• Serve as the primary interface for assigned projects.
• Engage early in project intervals, deliverables, and support requirements.
• Ensure execution of all key milestones to support on-time project delivery.

Process Improvement:

• Identify opportunities to enhance efficiency and apply best practices.
• Provide recommendations that support program development and execution.

Cross-Functional Communication:

• Communicate and collaborate with stakeholders at all organizational levels, including senior leadership.
• Lead weekly team meetings with project stakeholders and drive accountability for next steps and action items.
• Prepare and present weekly program summaries, including project status updates and resolution plans.

Issue, Risk, and Gap Management:

• Proactively identify project risks, issues, and gaps.
• Escalate concerns as needed and drive resolution to closure.
• Develop mitigation plans to address potential risks and delays.

Data Integrity and Analytics:

• Maintain accurate data within internal and external procurement databases.
• Use analytics tools to monitor supplier performance and identify compliance risks or operational bottlenecks.

Timeline and Documentation Management:

• Develop and maintain project timelines for legal documentation status, application progress, project milestones, and issue tracking.
• Document outputs from weekly team meetings and distribute updates to stakeholders.

Basic Requirements:

• Bachelor’s degree in Business Administration, Project Management, or a related field.
• 4 to 7 years of procurement experience, including both direct and indirect spend.
• Strong analytical background with proficiency in data management and analysis tools.
• Legal authorization to work in the United States indefinitely.

Required Experience:

• General procurement and supply chain experience.
• Google Suite: Google Sheets, Google Docs, Google Slides.
• Microsoft Office: Excel, Word, PowerPoint, Outlook.
• Tableau experience creating dashboards, reports, and data visualizations.

Preferred Skills:

• Coupa
• MTCM
• Agile ERP systems
• Oracle ERP systems

Preferred Certifications:

• PMP (Project Management Professional) certification is a plus.
• CAPM (Certified Associate in Project Management) certification is a plus.

Preferred Qualifications:

• Experience with international trade and global regulatory environments.
• Demonstrated ability to manage complex projects and cross-functional teams.
• Expertise in data visualization and advanced analytical modeling.
• Strong written and verbal communication skills.

Additional Preferred Experience:

• Experience working on federal contracts and familiarity with federal contract regulations is a strong plus.

Who We Are

SGF Global is an integrated talent solutions provider, offering staffing, recruitment, Employer of Record (EOR), nearshore, and consulting services across a wide range of industries in 35 countries. We’re a dynamic, people-first organization where fresh ideas are always welcome. Our culture is built on collaboration, innovation, and a genuine passion for helping people grow. At SGF Global, smiles are part of the dress code, and every voice matters.

Are you looking to join an organization where your ideas are valued, your growth is supported, and your work makes a global impact?

• Explore opportunities
• Grow your career
• Be part of something global
• Your future starts here.

Company Description

Venus et Fleur is a luxury rose atelier renowned for its meticulously handcrafted arrangements of real roses that maintain their freshness for over a year. Inspired by Parisian design, our roses are delivered in elegant keepsake boxes, creating a modern and luxurious gifting experience. Every arrangement is customized to customers’ specifications, offering a stunning array of patterns, letters, symbols, and an extensive color palette. Dedicated to artistry and innovation, our team ensures each exquisitely curated order reflects the highest standards of design and beauty.

Position Overview

The Inbound & Inventory Supervisor owns inbound execution, warehouse-controlled inventory accuracy, material availability, and warehouse standards. This role supervises 1–2 Inventory / Receiving Clerks and serves as the operational link between Supply Chain, Logistics, and Production to ensure clean material flow into and out of the warehouse.

This role is accountable for all inventory accuracy from dock receipt through warehouse storage and staged release to production. Once inventory is formally transferred to Production, ownership shifts.

In this business, small gaps create lost revenue. This role exists to eliminate those gaps inside the warehouse while ensuring safe handling, storage, and movement of all materials.

Leadership & Team Oversight

• Supervise and develop 1–2 Inventory / Receiving Clerks
• Set daily priorities for receiving, putaway, counts, replenishment, and staging
• Audit work for accuracy and scanning compliance
• Coach for detail, urgency, and disciplined execution
• Enforce SOP adherence across Receiving, Putaway, Picking, and Transfer to Production
• Hold team accountable for warehouse inventory standards

Inbound Management & Quality Control

• Lead receiving operations for florals, vessels, packaging, and consumables
• Validate quantities against POs prior to system receipt
• Inspect florals for quality and specification compliance
• Ensure lot tracking accuracy for florals
• Quarantine and resolve non-conforming materials
• Document and escalate vendor discrepancies within 24–48 hours
• Coordinate dock flow and inbound prioritization
• Ensure accurate labeling, LPN creation, and system transactions

Warehouse Inventory Accuracy & Control

• Maintain 98–99%+ accuracy for all warehouse-controlled inventory
• Design and execute A/B/C cycle count programs
• Lead daily cycle counts and reconciliation
• Perform documented root cause analysis on variances
• Identify recurring drivers of shrink within warehouse operations
• Implement corrective and preventative controls
• Monitor aging, at-risk, and space-constrained inventory

Cross-Functional & Logistics Coordination

• Partner with Logistics to understand inbound schedules, lead times, and container arrivals
• Align with Supply Chain on POs, forecasts, and inbound prioritization
• Anticipate space constraints based on inbound pipeline
• Adjust labor focus and urgency based on inbound risk
• Communicate material arrival timing and constraints to Production
• Escalate inbound delays that may affect service levels

Material Release & Production Interface

• Ensure accurate staging and system transfer of materials to Production
• Maintain clear physical and system boundaries between warehouse and production inventory
• Prevent undocumented movement of materials
• Support investigations of production-related discrepancies while maintaining ownership boundaries

Warehouse Standards & Safety

• Maintain a clean, structured, luxury-grade warehouse environment
• Ensure proper storage conditions for florals and packaging
• Enforce safe material handling practices and adherence to all warehouse safety procedures
• Identify and address safety risks related to storage, material movement, and equipment use
• Promote a proactive safety culture where hazards are reported and corrected immediately

KPIs

• 98–99%+ warehouse inventory accuracy
• 100% cycle count completion
• Zero preventable warehouse-driven stock-outs
• Inbound discrepancy resolution within 48 hours
• Reduction in warehouse-related shrink
• 100% lot traceability for florals within warehouse control
• Team scanning compliance > 99%

Qualifications

• 3–5+ years in inventory control or warehouse supervision
• Experience supervising small teams
• Strong WMS/ERP experience with lot tracking
• Experience coordinating with Logistics and Supply Chain
• Strong root cause and process control mindset
• Demonstrated continuous improvement mindset with the ability to identify process gaps and implement practical operational improvements
• Detail-driven, disciplined operator

Senior Business Analyst Life & Annuities

Onsite in WDM office 4 days a week

Contract

Overview:

We are seeking an experienced Senior Business Systems Analyst (AI Enablement) to support ***’s AI transformation initiatives. This role will partner with ***’s BSA team, IT leadership, and PMO to understand current SDLC processes, identify pain points, gaps, and inconsistencies across teams, and translate findings into a more streamlined, AI-enabled operating model.

The BSA will assess our current requirements elicitation process and help define how an AI-infused approach can significantly improve the thoroughness, completeness, and quality of user requirements specifically for consumption by an AI coding agent. This includes identifying cross-system dependencies, non-functional requirements, and user personas from initial requirement elicitation through Jira story creation. This role will help transform our BSA capabilities by leveraging custom-built AI solutions to accelerate cycle time, improve consistency, and reduce downstream rework.

This role will also define measurable success criteria and develop metrics to evaluate process improvements and AI impact across the SDLC: gathering requirements across several other SDLC-related AI initiatives and provide light project management support across multiple AI workstreams.

Key Responsibilities

Assess current BA workflows, documentation standards, and impact analysis processes from user requirement elicitation through Jira story creation, identifying gaps, redundancies, inconsistencies and improvements across teams.

Identify friction points and define AI-enabled use cases with measurable business outcomes.

Drive feedback loops for AI proofs of concept (POCs) delivered to teams by gathering structured user input, measuring adoption and effectiveness, and incorporating insights into iterative improvements.

Develop clear, actionable requirements including user stories, acceptance criteria, non-functional requirements, personas, and upstream/downstream system impacts.

Determine and help establish processes or patterns to ensure user requirements align with current system capabilities. Proactively identify cross-system dependencies, technical constraints, gaps, and system limitations in collaboration with engineering teams to ensure requirements are technically feasible and implementation-ready.

Support backlog grooming, sprint planning, demos, and pilot validation sessions.

Track progress across multiple AI initiatives, manage dependencies and risks, and maintain clear stakeholder communication.

Develop and maintain lightweight project plans, timelines, and status reporting to ensure AI initiatives remain aligned with business priorities and strategic objectives.

Required Qualifications

5+ years of Business Analysis or Business Systems Analysis experience in technology or software environments.

Strong requirements elicitation, documentation, and facilitation skills.

Experience working in Agile environments with cross-functional teams.

Practical familiarity with AI tools (e.g., Claude Code CLI, ChatGPT, Copilot) and understanding of AI concepts (LLMs, prompt engineering, AI governance, and AI risk considerations).

Strong systems thinking, structured communication, and stakeholder management skills.

Preferred Experience

Experience implementing AI or automation solutions within enterprise environments.

Familiarity with AWS AI services (e.g., AWS Bedrock) or other enterprise AI platforms.

Familiarity with Jira, Confluence, GitHub, or similar SDLC ecosystems.

Experience supporting PMO processes or managing multiple concurrent initiatives along with a functional understanding of Agile practices.

Financial services or insurance industry experience.

Success Measures

Successful delivery of an AI-enabled solution for ***’s BSA team.

Improved BA workflow efficiency, quality, and consistency.

High-quality, implementation-ready requirements that reduce downstream rework and delivery thrash.

Effective coordination, transparency, and measurable progress across AI initiatives.

Job Title: EHS Administrator

Location: Worcester, MA 01606

Duration: 3+ Months (Extension)

JOB DESCRIPTION:

• The EHS Administrator will work mainly with the Environmental, Health and Safety team on ongoing projects, while spending time supporting other functional areas on miscellaneous administrative tasks.
• The person in this role will get hands-on experience working in a Manufacturing environment, while providing support for ongoing process improvement.
• This is an opportunity for an individual to get exposure and familiar with various departments and activities which have a worldwide presence.

The main functions of the role include:

• Maintain compliance standards by updating Safety Data Sheets (SDS), procedures and process documents as required.
• Document all safety and environmental incidents as they are sent in, following through with recording corrective actions taken.
• Timely data entry on any and all Safety Risk Assessments that are completed by the teams.
• Working with plant supervision to perform Toxic Risk Assessment based on active Chemical inventory.
• Miscellaneous forms of data entry to keep policy, procedure and data up to date.
• Assisting EHS team in event planning, setup, and breakdown.
• Providing support with filing, photocopying, recordkeeping and organizing information
• Working with EHS to schedule appointments for Employees at Occupational Health Vendor of choice. This could include Hearing tests, Surveillance Physicals, Workers' Comp, etc.
• Organization of "Swag” Inventory (T-shirts, Storage Closets, Filing).
• Utilizing their educational background and communication skills, students will gain the opportunity to work with all departments to resolve issues and step in to assist where needed.
• Management of Training Gaps for the facility. Maintaining databases to record gaps closed and assist in holding management accountable to closing area gaps to help create a skilled and engaged workforce.
• Other duties as assigned.

REQUIREMENTS:

• Associate degree Business or related field of study, or currently in a program to complete degree.
• 2+ years Administrative Experience preferred.
• Ability to thrive in a fast-paced, ever-changing environment
• Competent in technical capacity, collaboration and credibility.
• Strong computer skills. Microsoft Suite of product experience including, Excel, Word, Access, and PowerPoint knowledge required.
• Possesses excellent interpersonal skills in order to assist internal, external, and potential partners. They must be able to operate well in a team environment to sustain ongoing relationships with colleagues.

Contract Remediation Paralegal

We are seeking a highly skilled Contract Remediation Paralegal to support the review and remediation of third-party contracts. This role requires independent contract analysis, identification of compliance and commercial gaps, and clear communication of risk exposure to senior leadership and suppliers.

The ideal candidate operates effectively with structured processes and minimal oversight, exercises strong judgment regarding escalation, and communicates complex contract issues clearly in both written and verbal form.

Responsibilities

• Conduct detailed reviews of third-party contracts (MSAs, SOWs, amendments, DPAs, etc.) to identify regulatory, financial, and operational gaps.

• Compare contract terms against required regulatory, policy, and category standards.

• Prepare structured gap analyses and remediation summaries for category leaders and senior leadership.

• Draft proposed remediation language and coordinate updates with internal stakeholders and third-party suppliers.

• Serve as a primary point of contact for category leaders regarding contract remediation status and risk exposure.

• Track remediation progress and maintain documentation to support audit and compliance requirements.

• Escalate material risks, non-compliance issues, and financial exposure appropriately and in a timely manner.

• Support financial and budget considerations related to contract amendments and supplier negotiations.

• Manage multiple contract remediation initiatives simultaneously across regions and time zones.

Skills

• Demonstrated experience reviewing and analyzing complex commercial contracts.

• Strong understanding of contract lifecycle management and remediation processes.

• Ability to identify contractual risk and articulate impact in business terms.

• Experience interacting with senior stakeholders and third-party suppliers.

• Excellent written communication skills (risk summaries, executive-ready briefings).

• Strong judgment regarding risk prioritization and escalation.

• High level of organization and process discipline.

• Ability to operate independently once provided clear procedures and objectives.

• Experience supporting procurement or category management teams.

• Exposure to regulatory remediation or compliance-driven contract updates.

• Experience working in a global environment across multiple time zones.

• Familiarity with contract management systems and remediation tracking tools.

Education

• College degree / Paralegal

• 3–7+ years of experience in contract management, legal operations, or paralegal roles.

Benefits Info:

Russell Tobin offers eligible employees comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness).

Immediate Hiring – Senior Cybersecurity Analysts (NIST CSF Remediation Specialists)

Job Title: Senior Cybersecurity Analysts (NIST CSF Remediation Specialists) – Gap Analysis

Location: Topeka, Kansas (Remote – but must come onsite if required)

Experience: 10 + Years

Visa: US Citizens only (Client requirement).

Role Summary:

Senior analysts will own the remediation program, converting assessment findings into executable actions. They will work with stakeholders across IT, security, and operations to build prioritized remediation plans and track implementation progress throughout the year.

Key Responsibilities:

• Review completed NIST CSF 2.0 assessment and gap analysis

• Translate gaps into actionable remediation tasks mapped to CSF functions and categories

• Lead working sessions to establish priorities, dependencies, timelines, and required resources

• Oversee remediation implementation across technology, process, and governance domains

• Build and maintain executive cyber dashboards (progress, risks, KPIs, heatmaps)

• Provide ongoing risk scoring, remediation validation, and monthly progress updates

• Identify obstacles, inefficiencies, or risks to remediation timelines

• Mentor junior analysts and ensure consistency in reporting and documentation

Required Qualifications:

• 15+ years in cybersecurity governance, risk, and compliance (GRC)

• Hands-on experience running NIST CSF remediation programs (1.1 or 2.0)

• Strong understanding of security controls, architecture, and risk quantification

• Ability to convert assessment findings into prioritized remediation actions

• Experience building dashboards for executive audiences

• Excellent communication, documentation, and stakeholder coordination skills

If you know someone suitable or are interested, please share resumes or tag relevant professionals.

#CyberSecurity #NISTCSF #CyberRisk #GRC #CyberSecurityJobs #KansasJobs #USCitizensOnly #ContractJobs

Title: Clinical Pharmacist

Duration: 10 months

Location: North Carolina within 60 miles of Durham (May require working onsite up to 2 days per week.) Durham North Carolina 27707

Shift Timing: M-F 8am - 5pm

Pay Rate: $65.15/hr.

Job Description:

• Engage Medicare members, pharmacies, and providers to close adherence and SUPD (Statin Use in Persons with Diabetes) gaps. Complete Comprehensive Medication Reviews (CMRs) with Medicare members.
• Make outreach to Medicare members to assist in removing barriers to medication adherence.
• Partner with pharmacies and providers to close adherence gaps when the Medicare member is unengaged or when the Medicare member requires assistance.
• Contact providers to close SUPD (Statin Use in Persons with Diabetes) gaps.
• Complete Comprehensive Medication Reviews (CMRs) with eligible Medicare members to give the member a better understanding of their medications and health.
• Send interventions to providers through fax or the CMR platform to alert the provider of potential drug interactions and adverse reactions, dose changes, adherence issues, etc.
• Provide counseling to Medicare members regarding medications.
• Provide Medicare members with information regarding their pharmacy benefits (ie. formulary, preferred pharmacy, supplemental benefits, etc.)
• Provide clinical guidance and support to the Pharmacy Quality Specialists.
• Review prior authorization requests and make determinations for drug products according to member benefits and coverage criteria.
• Report to utilization review statistics to corporate compliance committees.
• Review data and summarize daily utilization review numbers.
• Responsible for tracking compliance of review cases.
• Provide clinical guidance and support to the assigned pharmacy technicians.
• Knowledge of drug coding (NDC, GCN, GPI and USC) and NCPDP claims adjudication systems.
• Review guideline criteria for prior authorization and non-formulary drugs in support of Pharmacy and Therapeutics Committee function and pharmacy benefit design.
• Ensure and evaluate quality controls and implement opportunities for performance improvement in pharmacy practices.
• Research drug information to maintain drug knowledge and disease state understanding for application to prior authorization reviews.

Hiring Requirements:

• Bachelor's degree or advanced degree.
• 3+ years of experience in related field.
• Current states pharmacy license.

Top 3-4 Required Skills:

• Able to work on computers and has work from home experience.
• Pharmacist experience.

Nice to have Skills:

• Medicare and medicaid experience.
• Health Plan
• Managed care experience

Years of Experience:

• 3-5

Education/Certifications Required:

• Pharmacist license for the state.

Industry Specific Experience – required, ideal, necessary?

• Retail, HMO, DSP

Breakdown of Duties/Typical Day:

• Participating in comprehensive medication review.
• Cold calling members and reaching out on non adherence.

Do you have screening questions?

• Do you have any familiarity with Medicare STARs and metrics? If so, please explain.

Immediate need for a talented R&D Project Manager. This is a 12+ months contract opportunity with long-term potential and is located in San Diego, CA(Hybrid). Please review the job description below and contact me ASAP if you are interested.

Job ID:26-08555

Pay Range: $60 - $90/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Lead and manage multiple R&D programs and/or large-scale product development projects, from feasibility through commercialization, including Class II and/or Class III medical devices (with emphasis on electrically active/medical electrical equipment where applicable).
• Develop and maintain integrated program plans, timelines (Gantt charts), budgets, resource plans, and risk registers; proactively identify and mitigate risks across technical, regulatory, clinical, commercial, and electrical safety dimensions.
• Define project scope, objectives, deliverables, and success criteria; create and maintain project charters, work breakdown structures (WBS), and detailed schedules.
• Lead cross-functional core teams (R&D/Engineering, Quality, Regulatory Affairs, Clinical, Manufacturing, Marketing, and Operations) to execute program objectives; facilitate effective decision-making and resolve conflicts.
• Drive adherence to Design Control processes (21 CFR 820.30), risk management (ISO 14971), usability engineering (IEC 62366), basic safety and essential performance requirements for medical electrical equipment (IEC 60601-1 series), and other applicable standards throughout the product lifecycle.
• Provide regular status updates, executive-level reporting, and dashboards to senior leadership and stakeholders; communicate program progress, issues, decisions, and changes clearly and proactively.
• Support regulatory strategy development and submissions (e.g., 510(k), PMA, technical files for CE marking), including coordination of electrical safety testing, EMC compliance (IEC 60601-1-2), and collateral/particular standards as needed.
• Foster a collaborative, innovative, and compliant culture within program teams.
• Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and cross functional teams management.
• Lead cross-functional teams through identification of risks & mitigations, problem resolution and root cause analysis, corrective and preventive action.
• Develop and maintain integrated project plan with risk-based timeline, critical path milestones, resource allocation, roadmap with clear milestones for gap analysis, risk management, remediation, testing, certification and budget tracking to support certification goals
• Monitor the effectiveness and performance of the launch and project team and facilitate the development of contingency plans, recommending corrective actions as required.
• Ensure compliance with quality management systems and regulatory requirements, where applicable.
• Lead the team to prepare for and execute Phase Gate. Represent the team with Client leaders, ensuring such decisions are informed by a balanced and clearly articulated representation of the relevant data.
• Leverage technical acumen to partner with engineering teams, monitor development progress, and ensure alignment between technical deliverables and program timelines
• Drive design control discipline throughout product development, ensuring compliance
• Conduct or oversee gap assessments against general, collateral, and particular standards for medical electrical equipment safety and essential performance.
• Manage integrated risk management (per ISO 14971), including essential performance definition, hazard analysis, risk controls, and verification.
• Coordinate and manager the execution of test plans for electrical safety, EMC, mechanical, environmental, and essential performance requirements; coordinate pre-compliance and formal third-party testing.
• Oversee compliance documentation: technical files, risk management files, test reports, essential performance rationale, and certification justification.
• Integrate compliance activities with the quality management system (ISO 13485) and other regulatory requirements (FDA, EU MDR, etc.).
• Serve as primary liaison with notified bodies, test labs, and regulatory consultants to support certification and post-compliance needs.
• Drive a safety-focused culture while ensuring the team meets the September 2027 compliance target

Key Requirements and Technology Experience:

• Key Skills;Bachelor’s degree in Engineering (Biomedical, Electrical, Mechanical, or related),Life Sciences, or equivalent.
• 3-5 years of project management in medical devices, with ≥5 years leading compliance programs for medical electrical equipment.
• Proven track record of successfully delivering medical device programs from concept to market launch (including regulatory clearance/approval).
• Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971 risk management, IEC 62304 (software), and global regulatory pathways (510(k), De Novo, PMA, MDR).
• Proficiency with project management tools (e.g., MS Project, Jira, Smartsheet, or similar) and standard office software.
• Project Management Professional (PMP) certification not required but is preferred
• Scrum Master and SAFE Agile certification is preferred.
• Experience in medical device industries required, including experience in FDA or other regulated environments.
• Knowledge of the medical device industries beneficial integrating science and technology into business processes.
• Technical background in electrical, mechanical, or biomedical engineering
• Expert in the development and deployment of program management tools and techniques including methods for tracking progress, risk management and delivery of major milestones.
• Understanding of engineering development lifecycles and the ability to translate technical inputs into program-level actions and timelines
• Excellent influencing skills with the ability to achieve challenging goals through others without direct authority across different functions, external partners, geographies, and cultures.
• Drive for accountability within self and others.
• Proven project management experience with delivering medium-to large-scale projects in managed service model from concept through delivery and operations
• Relentless advocacy for the customer with a focus on meeting or exceeding customer requirements.
• Driving the team to make trade-offs that optimize customer and business value while maintaining program velocity and outcomes that sustain the highest standards of quality.
• Direct experience with major test labs and certification bodies for medical electrical equipment standards.
• Experience with programmable electrical medical systems (PEMS) or software-inclusive devices (IEC 62304 knowledge a plus)
• Proven success taking Class II (or higher) active medical electrical devices from gap assessment through third-party certification.
• Strong knowledge of ISO 14971, ISO 13485, general/collateral/particular standards for medical electrical safety and essential performance, and EMC requirements.
• Familiarity with FDA QSR (21 CFR Part 820), EU MDR/IVDR, or other global regulations.

Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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