Responsable Affaires Réglementaires - spécialiste produits combinés

JR France; Nancy; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

A leading company in Nancy is seeking a Senior Consultant in Regulatory Affairs. The role involves guiding regulatory projects for drug-delivery devices, collaborating with R&D teams, and ensuring compliance with EU and US regulations. Ideal candidates have extensive experience in regulatory affairs, excellent project management skills, and a strong educational background in relevant fields.

Qualifications

• 8–12 years of experience in Regulatory Affairs and/or R&D.
• Experience with drug-delivery devices and combination products.

Responsabilités

• Lead regulatory strategies for drug-delivery devices.
• Support R&D teams ensuring compliance with standards.
• Manage communications with notified bodies and health authorities.

Connaissances

Regulatory Affairs

Project Management

Cross-functional Collaboration

Formation

University degree in Biomedical Engineering

Pharmacy

Health Technology

Medical Science

Description du poste

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Client:

Beyond Conception GmbH

Location:

Nancy, France

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

69177547883020288327636

Job Views:

1

Posted:

15.05.2025

Expiry Date:

29.06.2025

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Job Description:

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 the lifecycle of 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 during development, from design control to quality management, ensuring compliance with standards and regulations.
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 sharing knowledge through internal training.

Your profile:

You are proactive, independent, and passionate about regulatory projects. You thrive in dynamic environments, adapt to client needs, and are committed to high-quality outcomes. You are eager to learn and share knowledge, demonstrating professional growth.

You possess:

• 8–12 years of experience in Regulatory Affairs and/or R&D related to:
• Drug-delivery devices (e.g., pre-filled syringes, autoinjectors, inhalers, vaccines, blow-fill seals).
• Combination products under EU and US frameworks.
• Quality Management Systems for medical devices and combination products.

Additional skills include:

• Experience with device development under design controls and technical standards.
• Supporting R&D through development phases of combination products.
• Managing projects and stakeholder relationships independently.
• Cross-functional collaboration with RA CMC, Manufacturing, Clinical, and Commercial teams.
• Handling audits and inspections with notified bodies, FDA, or NCA.

Education:

University degree in Biomedical Engineering, Pharmacy, Health Technology, Medical Science, or related field.

Languages:

Fluent in English (required), French (desired).