Manager, Regulatory Affairs
A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions that detect disease and contamination to improve patient health and ensure consumer safety. bioMérieux’s global headquarters is located in Marcy L’Étoile, France, and we have more than 11,200 team members in 43 countries. With our distributor network, we serve more than 160 countries. bioMérieux, Inc., our Americas division, has more than 4,000 team members across 12 sites or subsidiaries. Our Americas headquarters is in Durham, NC, with nearly 1,200 team members. bioMérieux, Inc. sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health. Our passionate team members recognize the power of diagnostics and rally behind our mission to help save lives.
This position will execute regulatory strategies; ensure adherence to policies and drive implementation of the regulatory processes as planned at Project/Program level.
- Assist in the recruitment and staff development,
- Plan resources for next budget; manage resources and control expenses within approved budget,
- Assess continuously Project output with consideration to evolving regulations; assess impact on resources and launch dates; adapt regulatory strategy and give feedback to Project
- Manage and monitor regulatory processes at Project/Product portfolio level to ensure timely execution,
- Assist in the development of answers to questions and in the interactions/negotiations with regulatory agencies of their representatives; review progress and report on issues, Provide feedback on the effectiveness of the regulatory processes (strategy, applications review with questions/answers, issues and problem resolution) and contribute to improvement plan.
- Bachelor’s degree in Science or Engineering,
- Knowledge of regulatory requirements, guidance documents and processes (local/regional) with 4+ years of practice in the field of IVDs/MDs in a regional environment,
- Basic knowledge of QMS requirements (QSR and/or ISO 13485 and/or local GMPs if appropriate) with knowledge of design and change controls,
- Familiar with product profiles and technology, company organization and processes,
- Familiar with local regulatory agency organization,
- Participation in local professional/trade organizations.
Skills and Qualifications:
- Can work in an international environment,
- Mentor and share experience,
- Analysis of moderate complexity issue and problem solving,
- Communicate to internal/external stakeholders and regulatory agencies or their representatives, Influence, challenge, and negotiate.
Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 11,200 bioMérieux team members who already identify with these values!
Learn more here
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA
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Job posted: 2020-07-13