Senior Regulatory Experts - Medical Devices

Employer

EMD Millipore Corporation

400 Summit Drive, Burlington, Massachusetts 01803
Job Site: 3050 Spruce Street, St. Louis, MO 63103
Telecommuting is an option, but the employee must be based in the St. Louis, MO region to conduct regular visits to company offices.

Senior Regulatory Expert - Medical Devices

At least 10% domestic and 5% international travel required per year.

• Oversee and define the roadmap for global regulatory submissions for US Class I and II and EU Class A, B, and C in‑vitro diagnostic medical devices to global regulatory agencies and/or commercial partners. Develop and implement strategic frameworks for determining compliance requirements for in‑vitro diagnostic products in the USA, EU, Canada, UK, Switzerland, Latin America, the Caribbean, and Asia Pacific.
• Provide regulatory insights and action plans to cross‑functional teams to ensure regulatory compliance, with particular focus on In‑Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), FDA 21 CFR 820, CMDR SOR 98‑292, IVDD 98/79/EC, ISO 13485:2016, IMDRF, and other applicable International Medical Device Regulations. Contribute to internal and external training of stakeholders.
• Independently author, compile, and maintain technical files and other regulatory documentation to ensure timely registrations and renewals in compliance with IVDR by strategically implementing digital solutions such as RPA tools, analytics tools, and ERP systems. Review technical dossiers compiled by other SMEs.
• Review and approve quality management system documentation related to post‑market surveillance, risk management, stability, and other conformity assessment requirements. Respond to deficiency letters from notified bodies and regulatory agencies.
• Respond to regulatory inquiries from internal and external customers and actively participate in inspections by authorities and notified bodies, implementing corrective and preventive actions (CAPA) as needed. Keep up to date on regulatory standard operating procedures for audit readiness.
• Implement defined strategic frameworks for assessing the regulatory implications of engineering changes to manufacturing processes and final products, facilitating informed decision‑making that aligns with compliance requirements and business objectives.
• Monitor and analyze global regulatory developments for in‑vitro diagnostic medical devices, lead regulatory surveillance and advocacy activities in accordance with regulatory intelligence procedures. Coordinate and facilitate training sessions for internal and external stakeholders.
• Manage the regulatory review process for labeling materials—including labels, instructions for use, package inserts, advertising/promotions materials, COAs, and websites—to ensure compliance with applicable global regulations.
• Provide regulatory assessment for new product development initiatives, identifying regulatory risks, tracking timelines, and submission deliverables to ensure alignment with regulatory requirements and market needs.
• Manage recall or notification actions as needed and ensure effective execution of regulatory vigilance reporting to global regulatory authorities.
• Mentor junior team members to support onboarding and development.

Employer requires a candidate to have at least a Bachelor of Science degree in pharmacy, biology, chemistry, pharmacology, chemical engineering, or a closely related field and at least seven (7) years of progressively more responsible work experience developing and implementing global regulatory strategies for in‑vitro diagnostic medical devices in compliance with Regulation (EU) 2017/746 (IVDR), European Directive 98/79/EC (IVDD), US FDA 21 CFR, UK MDR 2002, and Canada Medical Devices Regulations (SOR /98282).

Candidate must also have the following:

• Demonstrated knowledge of medical device or in‑vitro diagnostics regulatory compliance while applying Quality Management Systems (21 CFR Part 820, ISO 13485:2016, MDSAP, IMDRF) including risk management, labeling, post‑market surveillance, stability, and design controls, gained through at least five (5) years of…