Affaires Reglementaires jobs in United States

Beyond Conception GmbH

Other

-

Yes

69177547883020288327675

1

15.05.2025

29.06.2025

As an RA (Senior) Consultant, you will play a pivotal role in supporting pharmaceutical and medical device clients in the development, submission, and lifecycle management of drug-delivery devices and combination products. You will lead and guide various regulatory projects, providing expert advice on strategies, classifications, and pathways, while collaborating closely with R&D teams to develop new products or manage existing ones. Your responsibilities include:

1. Leading and implementing regulatory strategies for drug-delivery devices and combination products.
2. Providing guidance on regulatory classification and submission pathways for the EU (MDR, CE Marking) and the US (FDA, 510(k), PMA, NDA, BLA, ANDA).
3. Supporting R&D teams in development phases, ensuring compliance with standards and frameworks.
4. Liaising with internal stakeholders to compile dossiers and technical documentation for submissions.
5. Drafting and reviewing device sections of eCTD modules for applications.
6. Managing communications with notified bodies and health authorities, including audits and inspections.
7. Mentoring team members and contributing to internal training.

You are an independent, proactive professional passionate about regulatory projects, thriving in dynamic environments, and committed to high-quality outcomes. You are eager to learn and share knowledge, demonstrating strong professional development commitment. You possess:

• 8–12 years of experience in Regulatory Affairs and/or R&D related to drug-delivery devices and combination products under EU and US frameworks.
• Knowledge of Quality Management Systems (ISO 13485, MDR, 21 CFR 820, ISO 14971).
• Experience supporting development phases of combination products.
• Ability to manage projects and stakeholder relationships independently.
• Experience with audits and inspections by NB, FDA, or NCA.
• University degree in Biomedical Engineering, Pharmacy, or related fields.
• Fluency in English; French is a plus.