Responsable Affaires Réglementaires - spécialiste produits combinés

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

Résumé du poste

A leading company in the pharmaceutical sector seeks a Senior Regulatory Affairs Consultant. In this pivotal role, you will support clients in drug-delivery device development and lifecycle management, ensuring compliance with EU and US regulations. You will lead regulatory strategy, mentor team members, and manage communications during audits. Ideal candidates will have extensive experience in Regulatory Affairs, strong project management skills, and relevant degrees.

Qualifications

• 8–12 years of relevant experience in Regulatory Affairs and/or R&D.
• Experience with audits and inspections.

Responsabilités

• Leading and implementing regulatory strategy development.
• Compiling dossiers for regulatory submissions.

Connaissances

Project Management

Stakeholder Relationship

Fluency in English

Fluency in French

Formation

Degree in Biomedical Engineering

Degree in Pharmacy

Outils

Quality Management Systems

Description du poste

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Client:

Beyond Conception GmbH

Location:

Job Category:

Other

EU work permit required:

Yes

Job Reference:

69177547883020288327673

Job Views:

2

Posted:

16.05.2025

Expiry Date:

30.06.2025

Job Description:

As a Senior Regulatory Affairs (RA) 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. Your responsibilities will include:

1. Leading and implementing regulatory strategy development 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 technical standards and regulatory frameworks.
4. Compiling dossiers and technical documentation for regulatory submissions, liaising with notified bodies and health authorities.
5. Managing communications during audits and inspections.
6. Mentoring team members and contributing to internal training.

Your profile:

• 8–12 years of relevant experience in Regulatory Affairs and/or R&D related to drug-delivery devices and combination products under EU and US regulatory frameworks.
• Experience with Quality Management Systems for medical devices (ISO 13485, MDR, 21 CFR 820, ISO 14971).
• Strong project management and stakeholder relationship skills.
• Experience with audits and inspections.
• Degree in Biomedical Engineering, Pharmacy, or related fields.
• Fluency in English; French is a plus.