Job Postings
AMDM posts open positions within the IVD Industry.
The is no charge for AMDM Members for a 60-day posting. Non-members are charged $150 (Pay via our secure online store).
AMDM members are notified via email when a new posting is uploaded.
To post your open position, please send your job description (be sure to include how to apply for the position) and contact information to amdm_secretary@att.net. Jobs will be published on this page within 48 hours and a notice sent to the AMDM membership alerting them to the new posting.
The is no charge for AMDM Members for a 60-day posting. Non-members are charged $150 (Pay via our secure online store).
AMDM members are notified via email when a new posting is uploaded.
To post your open position, please send your job description (be sure to include how to apply for the position) and contact information to amdm_secretary@att.net. Jobs will be published on this page within 48 hours and a notice sent to the AMDM membership alerting them to the new posting.
Posted 10.21.20
Job Description:
Beaufort, LLC, a leading provider of regulatory, quality and clinical solutions for in vitro diagnostic companies is seeking an energetic, self-motivated individual who can fill the role of either Regulatory Affairs Manager or Senior Regulatory Affairs Specialist. The final title and salary will be commensurate with demonstrated experience. This is a remote position.
This position will support Beaufort’s Senior Vice President Regulatory & Quality and Beaufort’s clients in the development and implementation of global regulatory strategies and deliverables for marketed and developing IVD and medical device products. This role acts as a regulatory IVD/medical device Subject Matter Expert providing clients with consulting support for their needs related to compliance with the applicable regulations and standards. The successful candidate will perform work independently as a client-facing lead or as a contributor to regulatory projects within the stated scope of work and timeframes as established with clients.
Responsibilities include:
Provide a wide range of high-quality global Regulatory Affairs services to IVD and medical device companies which may include:
Qualifications:
Candidates may apply clicking on this link https://careers-beaufortcro.icims.com/jobs/2227/job or sending their resume to me at lpettrey@beaufortcro.com
Job Description:
Beaufort, LLC, a leading provider of regulatory, quality and clinical solutions for in vitro diagnostic companies is seeking an energetic, self-motivated individual who can fill the role of either Regulatory Affairs Manager or Senior Regulatory Affairs Specialist. The final title and salary will be commensurate with demonstrated experience. This is a remote position.
This position will support Beaufort’s Senior Vice President Regulatory & Quality and Beaufort’s clients in the development and implementation of global regulatory strategies and deliverables for marketed and developing IVD and medical device products. This role acts as a regulatory IVD/medical device Subject Matter Expert providing clients with consulting support for their needs related to compliance with the applicable regulations and standards. The successful candidate will perform work independently as a client-facing lead or as a contributor to regulatory projects within the stated scope of work and timeframes as established with clients.
Responsibilities include:
Provide a wide range of high-quality global Regulatory Affairs services to IVD and medical device companies which may include:
- Propose regulatory pathways (product classification assistance and requirements to bring product to market) for major global markets.
- Support pre-submissions and clinical strategies.
- Advise on regional submission requirements and prepare materials for regulatory submissions to allow for successful filings.
- Compile technical documentation to submit to local authorities in accordance with the requirements for US, Europe, and other global markets.
- Serve as liaison to regulatory agencies, conduct negotiations on behalf of sponsor teams, document decisions, and conduct debrief meetings; support multiple types of agency interactions/meetings.
- Conduct gap assessments of existing client documentation to evolving global regulatory requirements and revise or draft new documentation.
- Review client marketing materials for accuracy, including written documents and website content.
- Perform other regulatory consulting services as requested by clients, and help customize consulting solutions to clients' specific needs.
- Provide guidance to Business Development in determining appropriate scope and budget of proposals, including scoping calls with clients.
- Prepare and conduct business development and conference presentations on regulatory related topics, which showcase the individual's position as a subject matter expert; write White Papers.
- Independently research, prepare, and present on global regulatory topics to internal stakeholders.
- Monitor regulatory trends and be able to apply learnings and provide guidance or strategy related to such trends.
- Develop and maintain Corporate regulatory database of information (standards, guidance, etc.) and requirements for international registrations.
- Responsible for ensuring compliance with applicable Beaufort policies and procedures across the organization.
- Perform other duties & projects as assigned.
Qualifications:
- Bachelor’s degree or equivalent experience in a scientific discipline (e.g. Biochemistry, Biological Engineering, Chemistry, or similar).
- At least 3 years relevant MD/IVD regulatory affairs experience.
- Demonstrated knowledge and understanding of current and evolving federal (e.g., 21 CFR 820) and international procedures (e.g., IVDR, CMDR, JPAL) and standards (e.g., ISO 13485, ISO 14971) relevant to the registration/clearance/approval and post-market surveillance of diagnostics.
- Extensive hands on experience writing and reviewing technical regulatory and clinical documents.
- Exceptional writing skills and verbal interpersonal skills to influence many diverse internal/external customer groups.
- Ability to work independently on multiple projects with tight/changing deadlines.
- Ability to work on assignments where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
- Exceptional attention to detail, organization, interpersonal and judgment skills.
- Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio.
- Travel up to 10% of the time (post Covid).
Candidates may apply clicking on this link https://careers-beaufortcro.icims.com/jobs/2227/job or sending their resume to me at lpettrey@beaufortcro.com