Assembly Language Compiler Online Jobs in Usa
5 positions found
Provide executive administrative support by performing the following duties:
English and Japanese (Fluent with speaking, interpretation, understanding, reading and writing in both languages).
DUTIES AND RESPONSIBILITIES:
- Perform a full range of clerical and administrative support functions.
- Assist the Corporate Planning Department in preparing and summarizing financial information using Excel, Word, and PowerPoint.
- Create high level presentation of financial information, trend analysis, etc. Prepare monthly summary reports for reporting to shareholders.
- Perform market research on various industries and countries, as directed. Create market trend analysis presentation using data from multiple sources, being able to review content and accuracy of data and then summarize in well developed reports.
- Support the compilation of reports and application procedures with the administration teams of Japanese shareholders for the Corporate Planning Department.
- Discreet and organized assistance with personal tasks for expatriate executives.
- Coordinate and maintain CEO and executive team members calendars and keep supervisor informed of appointments
- Establish and respond to changing deadlines and priorities. Accept and/or decline invitations to meetings on behalf of CEO and executive team members'
- Handle all meeting room logistics for executive meetings. Secure materials and documents for meetings in advance of meetings.
- Coordinate CEO and executive members' travel arrangements. Arrange schedule of visits and transportation; notify organizations and officials to be visited
- Prepare and process CEO's expense reimbursement reports.
- Greet and direct CEO's guests, screen calls, answer questions and handle routines matters. On occasion, arrange luncheon for executives' meetings, office functions, appointments and entertaining events at the request of CEO and/or executives.
- Create and maintain documents and records; prepare meeting and conference materials
- Establish and maintain a good filing system.
- Translate Japanese documents into English and vice versa when requested. Provide support for Executive meetings by editing, copying, assembling and distributing meeting materials.
- Receive, sort and prioritize all CEO's correspondence and reply to mail not requiring CEO's attention or at the request of CEO.
- Handle confidential and/or sensitive information, while maintaining confidentiality at all time.
- Prepare high quality PowerPoint presentations for Executive meetings, reports to shareholders, etc.
Administrative background and proficient in Microsoft Office products – Word, Excel and PowerPoint Bilingual – English and Japanese (Fluent with speaking, interpretation, understanding, reading and writing in both languages). Proficient in managing tasks and collaborating across global time zones to ensure seamless operations. Basic practical experience in accounting processes. Exceptional communication and interpersonal skills, particularly in working with expatriates. Ability to work well with various departments. Demonstrate cultural sensitivity and appropriate business conduct at all time. Flexibility to adjust to changing priorities and handle multiple diverse projects under time constraints.
EDUCATION AND WORK EXPERIENCE:
Bachelor's degree and 5 years relevant experience
WORK ENVIRONMENT
- Usual office working conditions
Benefits information:
Benefits include medical, dental, vision, retirement, 401k and PTO
Equal Employment Opportunity Statement:
Noor Group and it's client are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic."
Physical Requirements:
This position requires the ability to perform the essential functions of the role, which may include standing for extended periods, bending, reaching, and lifting up to 50 pounds on an occasional basis, with or without reasonable accommodation. Physical demands may vary depending on assignment and client-site requirements.
Amphenol CMT is a leading innovator in the design and manufacturing of advanced medical devices that transform and elevate patient care. We specialize in engineering high-performance interconnects, flex circuits, molded components, precision bearings, and fully integrated solutions for surgical, interventional, monitoring, and other mission-critical applications.
Guided by a culture of innovation, collaboration, and lean principles, we deliver exceptional solutions and premium service that set new standards in the industry.
As part of the global Amphenol family—one of the world’s largest providers of high-technology interconnect, sensor, and antenna solutions—CMT is proud to contribute to products that enable the electronics revolution and improve lives worldwide.
MicroConnex, a CMT business unit, is a recognized leader in developing and fabricating specialized flex circuit technologies for high-density, demanding applications—further expanding our expertise and impact across critical industries.
SUMMARY
The Production Supervisor works under the supervision of the Manufacturing Manager. The Production Supervisor is responsible for supervising employees engaged in the manufacturing of products within quality, time, and cost standards. Additional responsibilities include enforcing safety protocols, implementing and monitoring process improvements, maintaining process control and troubleshooting documentation.
ESSENTIAL JOB FUNCTIONS
- Oversee production and quality of products to ensure MCX produces defect-free products which meet or exceed customer expectations, on schedule, and to customer requirements.
- Closely monitor operational performance to meet goals and objectives established by the company using plant metrics as a tool for continuous improvement.
- Establish and maintain tiered reporting and problem solving
- Maintains productions processes. Ensures minimal machine downtime by ensuring workstations are staffed, work orders and materials lined up, and set-up times kept to schedule.
- Direct and supervise all personnel involved with the production/manufacturing of products.
- Provides training and development; coaches and develops employees within assigned areas, fostering open communication within the group to promote teamwork. Ensures team is cross trained to support scheduling flexibility according to site standards.
- Responsible for planning and directing the workflow, assembly methods and workforce utilization for MCX
- Ensures all Quality system procedures and documentation requirements are consistently followed.
- Ensures all company policies including workflow and safety are followed and enforced.
- Conducts regularly scheduled safety meetings in accordance with OSHA standards and in accordance with company’s written safety policy and procedures
- Documents all training records for production/manufacturing employees to ensure all appropriate and mandated training is completed and properly documented.
- Performs set-up machinist job duties in order to meet quality, cost, and on-time delivery goals.
- Promotes and holds team accountable for 5S and good manufacturing practices, COS (Cost of Sales), and Lean problem solving. Participates in and supports kaizens and other CI activities.
- Build and develop a high-performing team through coaching, mentoring, and structured development plans.
- Champion employee engagement through regular feedback, recognition, and open communication.
*Other duties as required in support of the department and the company*
SUPERVISOR RESPONSIBILITIES
Supervisory responsibilities involve overseeing and managing a team or individual to ensure adequate performance and job satisfaction and contribute to individuals’ career goals.
QUALIFICATIONS
To succeed in this job, an individual must satisfactorily perform each essential job function. The requirements below represent the required knowledge, skill, and ability. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
EDUCATION and EXPERIENCE
- Bachelor’s degree in Engineering, Business or a related field.
- 3+ years of experience in manufacturing, with supervisory and work planning experience.
- Experience in 5S and Lean practices.
- Background in electronics and regulated discrete manufacturing environments, preferred.
CERTIFICATES, LICENSES, REGISTRATIONS
- Lean Six Sigma Green Belt Certified a plus
LANGUAGE REQUIREMENTS
- Excellent verbal and written communication skills in English.
MATHEMATICAL SKILLS
- Ability to work with mathematical concepts such as probability and statistical inference.
JOB SKILLS
- Advanced in MS Office Suite and SharePoint.
- Advanced knowledge of ERP systems, SAP preferred.
- Excellent interpersonal and communication skills.
- Demonstrates good judgment and decision-making skills
- Excellent management and communication skills. Able to adapt management, training, and communication style to the needs of their team or individual employees.
- Strong teamwork and relationship-building skills. Effectively communicates and builds trust with site leadership and other departments. Leverages relationships to advance the needs of the site.
- Proficient in MS Office. ERP experience a strong plus.
- Ability to manage multiple priorities in a manufacturing plant environment
- Understanding and experience in Lean manufacturing environment. Able to drive continuous improvement projects within their own team and area.
PHYSICAL DEMANDS
As part of their job duties, the employee must sit for lengthy periods while operating a computer. They frequently use their hands to type, handle objects, and communicate verbally. Additionally, they will need to stand, walk, and reach regularly, and occasionally lift objects weighing up to twenty (20) pounds. This role requires lifting, carrying, pushing, pulling, reaching overhead, reaching at or below shoulder level, and keyboarding. According to ADA regulations, reasonable accommodation will be provided to ensure that individuals with disabilities can perform the job's essential functions.
WORK ENVIRONMENT
Manufacturing environment: A work environment in a manufacturing plant is the physical and social setting where goods production occurs. Depending on the type of product, process, and plant, the work environment may vary in terms of noise, temperature, safety, and demand. Common characteristics of a work environment in a manufacturing plant are the use of machinery and exposure to hazards such as chemicals, heat, dust, or noise, with a culture of teamwork, communication, and continuous improvement.
ENVIRONMENTAL POLICY
Amphenol CMT is fully committed to minimizing the environmental impact of its operations, activities, and products. To achieve this, we adhere to all applicable environmental regulations and laws, prevent pollution, and continuously improve our environmental performance in all our global operations. This is possible through an Environmental Management System that provides a framework for setting and reviewing our environmental objectives and targets. We aim to identify and reduce any negative environmental impact our business activities may have.
PERSONAL PROTECTIVE EQUIPMENT REQUIREMENTS
- ASTM F–2412–2005, ANSI Z41–1999, or ANSI Z41–1991 rated safety toe shoes in specific areas.
- Clear ANSI Z87.1 safety-rated glasses in specific areas.
- Hearing protection in specific locations.
- Ability to compile with JSA in specific areas.
EXPORT COMPLIANCE DISCLAIMER
This position includes access or potential access to ITAR and EAR (Export Administration Regulations) technical data. Therefore, candidates must qualify as US Persons, defined as US Citizens or Permanent Residents (Green Card Holders).
TRAVEL
Approximately 10% of travel is expected, both international and domestic.
SALARY INFORMATION:
According to several states' laws, this position's salary range falls between $80,000 – $100,000 annually. However, this salary information is merely a general guideline. When extending an offer, Amphenol Critical Medical Technologies considers various factors such as the position's responsibilities, scope of work, candidate's work experience, education/training, essential skills, internal pay equity, and market considerations.
Certain roles are also eligible for additional rewards, including merit increases and annual bonus. These awards are discretionary and allocated based on individual and company performance. U.S.-based employees have access to medical, dental, and vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, and wellbeing benefits, among others. U.S.-based employees also receive, per calendar year, up to 11 scheduled paid holidays, up to 80 hours of paid time off and sick paid time off.
Paragon’s experienced professional staff is dedicated to producing high-quality documentation and providing safe field execution to support its clients’ projects in line with local, state and federal guidelines and regulations.
About this position: Detention Facility ERO Case Worker – El Paso, TX The Essential Duties and Responsibilities are intended to present a descriptive list of the range of duties performed for this position and are not intended to reflect all duties performed within the job.
Other duties may be assigned.
To perform this job successfully, an individual must be able to satisfactorily perform each essential duty.
The requirements listed below are representative of the knowledge, skill and/or ability required.
Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of the position.
Applicants will be notified via phone or email within ten (10) business days of submittal.
Essential Duties & Responsibilities The contractor shall provide case processing and administrative support to augment ICE’s mission, alleviating the administrative burdens of law enforcement officers.
The contractor shall provide specialized subject matter expertise, qualified personnel, and administrative resources necessary to enable ICE personnel to focus on law enforcement duties while administrative tasks are handled by trained contractor personnel.
Accordingly, the contractor shall: a.
Provide trained personnel to supplement case processing and all peripheral activities, immigration records management, and document preparation b.
Ensure accurate and timely data entry into ICE systems c.
Track compliance with release conditions and report violations d.
Coordinate with ICE officers to facilitate interviews, hearings, removals, and case updates e.
Maintain alien records in accordance with DHS policies and federal data security requirements f.
Provide other logistical and administrative support that alleviates administrative burdens from law enforcement officers.
g.
Participate in ERO provided training applicable to case processing and administrative support.
h.
Perform as a liaison with detainees and aliens regarding immigration related communications with ICE officers.
Task 1: Project Management and Programmatic Support To complete the tasks, the contractor shall interface with ICE Headquarters staff, local Field Office staff including Field Office Directors (FODs), program staff, facility staff, other Department of Homeland Security (DHS) and Department of Justice officials, and third-party service providers.
Personnel shall be available 7 days a week from 7am to 7pm in accordance with local field office requirements.
Surge support after hours, including expanded breadth and depth of tasks, may be required.
The contractor must maintain a staffing pool who can consistently leverage immigration enforcement experience and/or training to provide staff augmentation, technical assistance, and operational force multiplication.
Contractor personnel must have experience and/or training reviewing ICE documentation including A-files and ICE databases, conducting interviews to determine appropriate monitoring or detention conditions, and coordinating removal, transfer, or release from ICE custody.
The contractor must provide personnel who have the required skills prior to assigning them to work under this contract.
The contractor must establish and implement quality assurance procedures to validate work products assuring consistency of quality.
Task 2: Case Processing & Docket Management Contractor shall manage assigned administrative functions to ensure Alien Files (A-files) and ENFORCE Alien Removal Module (EARM/EADM) reflect a case status that is updated, accurate, and complete in preparation for Department of Justice (DOJ) Executive Office for Immigration Review (EOIR) appearances, United States Citizenship and Immigration Services (USCIS) adjudications, enforcement actions, or removal.
a.
Assist ICE Office of Principal Legal Advisor (OPLA) in obtaining criminal history checks and other supporting documentation as needed prior to court b.
Prepare, review, and manage case files, ensuring accuracy and completeness in all documentation c.
Maintain up-to-date case status records, court scheduling details, and case tracking logs d.
Assist with docket coordination for EOIR hearing schedules and ensure all appropriate documentation has been filed with EOIR e.
Assist with docket coordination for USCIS adjudications and ensure all appropriate documentation has been submitted to USCIS f.
Review appropriate paperwork for filing an Application for Stay of Deportation/ Removal, Order of Supervision (OSUP) or Own Recognizance (OR) reporting, Bond applications, or other documentation for completeness and accuracy g.
Ensure all administrative applications are reviewed, A-files are updated, and docket officers timely notified for appropriate law enforcement action.
Task 3: Data Entry & Records Management a.
Accurately enter data into ICE systems, ensuring compliance with agency protocols and data integrity requirements b.
Coordinate with ICE to address data quality and integrity issues c.
Maintain and update electronic and paper-based case files, ensuring compliance with federal privacy laws d.
Retrieve, compile, and organize county, state, and federal court records, conviction documents, and supporting case materials from multiple databases, including National Crime Information Center (NCIC), Public Access to Court Electronic Records (PACER), and other government sources.
e.
Generate case status reports and monitoring dashboards.
Task 4: Detainee Communication The contractor shall schedule interviews between detainees and ICE officers, consulates, and legal representatives for detained aliens to communicate with ICE for general questions, case updates, or resolve issues regarding their removal cases.
Communication with all aliens will be in the alien’s primary language.
In addition, the contractor will: a.
Receive and coordinate with ICE to respond to detainee communication.
ICE retains responsibility for approving responses.
b.
Maintain and log all communication sheets in an electronic format that captures pertinent information.
At minimum, the log must include the alien's name, alien record number (A#), date, time, content of communication, copy of communication, resolution and date of response.
The log must be made available to ICE upon request.
c.
Elevate any urgent or serious complaints or issues immediately to ICE.
Task 5: Removal Management Assistance 5.1 Pre-Removal In preparation for alien removal, transfer, or release from ICE custody, the contractor shall: a.
Manage administrative aspects of detained case management for immigration hearings, file updates and data entry b.
Organize and prepare removal documents and coordinate with the ICE Field Office, ICE Air Operations, and the Juvenile and Family Management Division (JFMD) for scheduling removal and staging flights c.
Ensure aliens scheduled for removal have the necessary documentation in A-files, i.e.
Immigration Judge (IJ) order, I-205 prepared with photograph, and all removal package documentation is assembled per specific field office instructions d.
Ensure I-216, property receipts, I-203s and other release, removal, or transfer documentation is prepared and accurate e.
Ensure travel information, ICE Air scheduling and manifest(s) are completed, detention center release forms are prepared, and property inventories/receipts are ready on the scheduled time and day of departure f.
Ensure detainees have necessary legal paperwork, seven-day supply of medications, property, and valuables before transfer or removal, including obtaining and verifying travel documents 5.2 Post Removal a.
Collect, review for completeness and accuracy, and file signed Form I-205 Warrant of Removal/Deportation departure verifications in A-file b.
Ensure case is closed in EARM and file is transferred to the National Record Center for storage Required (Minimum Necessary) Qualifications • Education Requirements: High School Diploma • Level of Experience Requirements: 1 year of ICE administrative or detention work Knowledge, Skills, Abilities, and Other Characteristics • Knowledge, Skills and Abilities • Physically capable of responding to emergencies, such as running with a fire extinguisher.
• Capable of understanding and applying written and verbal orders, rules, and regulations.
• English literacy and ability to write reports in English • Meet and maintain physical/health requirements for duties.
• Ability to use Computer Programs, such as Microsoft Excel and Word.
Preferred • N/A Necessary Physical Requirements The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Employees must always maintain a constant state of mental alertness.
Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Applicants must be able to pass a physical exam equivalent to the ICE deportation officer physical exam.
Applicants must be able to perform through pat-down searches and be able to physically search physical structures for contraband.
Applicants must be able to respond to emergency situations, such as fires and run for prolonged distances with a fire extinguisher.
Applicants must also be able to respond to physical disturbances that are violent in nature.
Applicant must be able to assist in quelling physical altercations, as well as defending themselves from physical assault.
Work Environment Work Environment characteristics described here are representative of those that must be borne by an employee to successfully perform the essential functions of this job.
• Job is performed in a multitude of settings.
There are various positions that could tentatively be performed on any given 8 – 12 hour day.
These include the following: • Exposure to extreme climate temperatures and conditions • Exposure to sun and climate conditions, to include standing up and/or walking for more than 8 hours.
• Sitting at desk and periodically walking to conduct security checks • Utilizing computers in offices or buildings • Confined to office space for more than 8 hours Shareholder Preference BSNC gives hiring, promotion, training, and retention preference to BSNC shareholders, shareholder descendants and shareholder spouses who meet the minimum qualifications for the job.
Bering Straits Native Corporation is an equal opportunity employer.
All applicants will receive consideration for employment without regard to any status protected by state or federal law, or any other basis prohibited by law.
Company:Qualcomm Technologies, Inc.Job Area:Engineering Group, Engineering Group > DSP Architecture and Design
General Summary:
Qualcomm is seeking a low-level embedded engineer with a strong foundation in software and processor architecture to help shape architectural features and deliver measurable performance enhancements on Qualcomm’s Neural Processing Unit (NPU). This role will work across the instruction set architecture, operating system, and processor architecture, partnering tightly with hardware and software teams to turn ML workload insights into architecture and software optimizations.
The ideal candidate will be proficient in processor architecture, C/C++ and assembly, embedded operating systems, and performance profiling tools. Experience with AI workloads and large language models (LLMs) is a plus but not required.
Responsibilities:
- Model, benchmark, and analyze performance of multi-threaded and multi-processor software.
- Identify and resolve performance bottlenecks across software, architecture, and micro-architecture layers.
- Analyze ML KPIs to guide optimization efforts.
- Collaborate with cross functional teams (architecture, compiler/runtime, kernel/RTOS, drivers, ML frameworks) to land optimizations in production.
- Author clear design documents, performance studies, and best software practices.
- Stay current with advancements in computer architecture, micro-architecture, and AI model design.
Qualifications:
- Proficiency in debugging, performance analysis and profiling.
- Strong background in operating systems, computer architecture, and micro-architecture (pipelines, caches, memory hierarchy, coherence).
- Experience with multi-threaded and multi-processor systems.
- Strong programming skills in C/C++, Python, or similar.
- Excellent problem‑solving skills, attention to detail, and clear written/verbal communication.
- Ability to collaborate across hardware/software domains.
Preferred Skills:
- Hands-on experience with debugging (gdb, lldb, winDbg or similar) and performance profiling tools (perf, VTune, Nsight or similar).
- Familiarity with SIMD and SPMD execution models.
- Understanding of hardware-software co-design principles.
- Familiarity with linear algebra, and precision aware arithmetic is a plus.
- Understanding of how ML architectures map to the hardware is a plus.
- Knowledge of ML frameworks and libraries (ggml/llama.cpp or similar) is a plus.
Requirements:
- Bachelor’s degree in Electrical Engineering, Computer Science, Computer Engineering, or related field and 2+ years of relevant experience, OR
- Master’s degree in a related field and 1+ years of relevant experience, OR
- PhD in a related field.
Minimum Qualifications:
• Bachelor's degree in Electrical Engineering, Computer Science, Computer Engineering, or related field and 2+ years of Software Engineering, Electrical Engineering, Systems Engineering, or related work experience.OR
Master's degree in Electrical Engineering, Computer Science, Computer Engineering, or related field and 1+ year of Software Engineering, Electrical Engineering, Systems Engineering, or related work experience.
OR
PhD in Electrical Engineering, Computer Science, Computer Engineering, or related field.
• 2+ years of experience with high-performance microprocessor design.
Qualcomm is an equal opportunity employer. If you are an individual with a disability and need an accommodation during the application/hiring process, rest assured that Qualcomm is committed to providing an accessible process. You may e-mail or call Qualcomm's toll-free number found here. Upon request, Qualcomm will provide reasonable accommodations to support individuals with disabilities to be able participate in the hiring process. Qualcomm is also committed to making our workplace accessible for individuals with disabilities. (Keep in mind that this email address is used to provide reasonable accommodations for individuals with disabilities. We will not respond here to requests for updates on applications or resume inquiries).
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Qualcomm. Staffing and recruiting agencies and individuals being represented by an agency are not authorized to use this site or to submit profiles, applications or resumes, and any such submissions will be considered unsolicited. Qualcomm does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to our jobs alias, Qualcomm employees or any other company location. Qualcomm is not responsible for any fees related to unsolicited resumes/applications.
EEO Employer: Qualcomm is an equal opportunity employer; all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, Veteran status, or any other protected classification.
Qualcomm expects its employees to abide by all applicable policies and procedures, including but not limited to security and other requirements regarding protection of Company confidential information and other confidential and/or proprietary information, to the extent those requirements are permissible under applicable law.
Pay range and Other Compensation & Benefits:
$127,200.00 - $190,800.00The above pay scale reflects the broad, minimum to maximum, pay scale for this job code for the location for which it has been posted. Even more importantly, please note that salary is only one component of total compensation at Qualcomm. We also offer a competitive annual discretionary bonus program and opportunity for annual RSU grants (employees on sales-incentive plans are not eligible for our annual bonus). In addition, our highly competitive benefits package is designed to support your success at work, at home, and at play. Your recruiter will be happy to discuss all that Qualcomm has to offer – and you can review more details about our US benefits at this link.
If you would like more information about this role, please contact Qualcomm Careers.
Senior Regulatory Consultant- Lead - Mexico
Responsibilities:
- Creation of regulatory strategies with the client regulatory team to guarantee approval by the Ministry of Health.
- Support in the creation of a high performance team to carry out the necessary activities in the designated project by the client regulatory team.
- Lead the team of consultants to meet the project objectives
- Preparation, compilation, and coordination of high-quality regulatory submissions for new product launches, product updates, and throughout product lifecycle.
- Ensure that documents to be submitted to health authorities are ready by ensuring quality review is performed before forwarding to client regulatory personnel.
- Research, draft and assemble the documents required to secure export certificates, market specific product applications/ notification and health authority clearances
- Support for CMC dossier preparation and review
- Review of artwork changes and associated change controls, including tracking of deliverables.
- Monitoring of new and changing regulatory standards and dissemination of information.
- Support coordination of label change initiation, label reviews and changes in accordance with regional /country review system and procedure.
- Provide regulatory input, review and approval related to change control
- Support product portfolio through execution of legal document activities as required
- Coordination with cross functional teams for collating labels and COA’s of API, excipients and finished product.
- Coordination with cross functional teams, manufacturing site and local affiliates for the required information to process the documents
- Search different internal tools for the required information to process the documents.
- Preparation and compilation of regulatory documentation for submission to local country
- Develop and manage regulatory action item tables for country specific requirements
- Mapping, coordination of regulatory inputs and timing end to end for country requirements resulting from legal entity change e.g., documentation required, timelines for registrations/notifications and phase-in of changes to meet compliance requirements
- Communicate internally and monitoring deliverables ensuring country requirements are met by specified timeframes
- Record and publish meeting notes. Incorporate follow-up items to project deliverable tracking, ongoing monitoring, and issue escalation to client local managers.
- Manage regulatory action item (task) tables including mapping, coordination of regulatory inputs, and timing
- Work with client regulatory managers to develop project implementation plans and manage workload planning to ensure on time completion of projects and tasks
- Support client regulatory managers in their registration procedure
- Complete market impact assessments
- Generation of databases and checklists for project monitoring
- Support in the creation of product history and archives
- Company systems update
- Provision of weekly updates (at a minimum) to relevant client regulatory managers
- Ensure regulatory standards and timelines are met
- Plan and track the status of ongoing regulatory projects
- Regulatory action item tables for country specific requirements and importation/ exportation needs for change in legal entity
- Presentation materials for management updates
- Ensuring documents for health authority are submission-ready
- Supporting coordination of label change initiation, label reviews and changes in accordance with regional /country review system and procedure.
- Regulatory input, review and approval related to Change Control
Experience/Qualifications:
- Regulatory professional with formal college or higher education in science related discipline
- Relevant work experience with minimum 5+ years in regulatory affairs
- Individuals must have fluency of English and local language.
- Good understanding of local regulations for OTC,Cosmetics and Medical devices
- Strong working knowledge of Microsoft Word, Excel, Power Point
- Good communication and follow up skills with country regulatory liaisons for clear understanding of country specific needs for registrations, license updates and import/export requirements.
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