Responsable Affaires Réglementaires - spécialiste produits combinés

JR France; Cherbourg-en-Cotentin; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A leading company is seeking a Senior Regulatory Affairs Consultant to support pharmaceutical and medical device clients. This role involves developing regulatory strategies, guiding submissions, and collaborating with R&D teams. The ideal candidate will have extensive experience in Regulatory Affairs, strong knowledge of compliance standards, and the ability to mentor others.

Qualifications

• 8–12 years experience in Regulatory Affairs or R&D related to drug-delivery devices.
• Knowledge of ISO 13485, MDR, 21 CFR 820, ISO 14971.

Responsabilités

• Developing and implementing regulatory strategies for drug-delivery devices.
• Providing guidance on EU and US submission pathways.
• Compiling dossiers and technical documentation for submissions.

Connaissances

Independent

Proactive

Passionate about regulatory projects

Fluent in English

Knowledge of quality management systems

Formation

Degree in Biomedical Engineering

Degree in Pharmacy

Description du poste

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Client:

Beyond Conception GmbH

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

69177547883020288327654

Job Views:

1

Posted:

15.05.2025

Expiry Date:

29.06.2025

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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. 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. Developing and implementing regulatory strategies for drug-delivery devices and combination products.
2. Providing guidance on EU (MDR, CE Marking) and US (FDA, 510(k), PMA, NDA, BLA, ANDA) submission pathways.
3. Supporting R&D in design control and quality management to ensure compliance with standards and regulations.
4. Compiling dossiers and technical documentation for submissions, liaising with notified bodies and health authorities.
5. Managing communications and participating in audits and inspections.
6. Mentoring team members and sharing knowledge through internal training.

Your profile:

• Independent, proactive, and passionate about regulatory projects.
• Experience of 8–12 years in Regulatory Affairs or R&D related to drug-delivery devices and combination products under EU and US frameworks.
• Knowledge of quality management systems such as ISO 13485, MDR, 21 CFR 820, ISO 14971.
• Experience supporting R&D through development phases and managing multiple stakeholder relationships.
• Proven ability to handle audits and inspections.
• Degree in Biomedical Engineering, Pharmacy, or related fields.
• Fluent in English; French is a plus.