Responsable Affaires Réglementaires - spécialiste produits combinés

JR France; Bourg-en-Bresse; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

A leading company is seeking a Senior Consultant in Regulatory Affairs to support pharmaceutical and medical device clients. The role involves developing regulatory strategies, guiding projects, and ensuring compliance with EU and US regulations. Ideal candidates will have extensive experience and a relevant degree.

Qualifications

• 8–12 years of experience in Regulatory Affairs or R&D.
• Knowledge of Quality Management Systems for medical devices.

Responsabilités

• Developing regulatory strategies for drug-delivery devices.
• Managing communications with notified bodies and health authorities.
• Mentoring team members and contributing to internal training.

Connaissances

Regulatory Affairs

Project Management

Cross-functional Collaboration

Formation

Degree in Biomedical Engineering

Degree in Pharmacy

Description du poste

Client:

Beyond Conception GmbH

Location:

Not specified

Job Category:

Other

-

EU work permit required:

Yes

Job Reference:

69177547883020288327674

Job Views:

1

Posted:

15.05.2025

Expiry Date:

29.06.2025

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 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 regulatory classifications 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, ensuring compliance with standards and frameworks.
4. Compiling dossiers and technical documentation for regulatory submissions in collaboration with internal stakeholders.
5. Managing communications with notified bodies and health authorities, including audits and inspections.
6. Mentoring team members and contributing to internal training.

Candidate Profile:

You are an independent, proactive professional passionate about regulatory projects, adaptable in dynamic environments, eager to learn, and committed to professional growth. You should possess:

• 8–12 years of experience in Regulatory Affairs or R&D related to drug-delivery devices and combination products under EU and US frameworks.
• Knowledge of Quality Management Systems for medical devices and combination products.
• Experience supporting R&D through development phases and managing projects independently.
• Strong cross-functional collaboration skills.
• Proven experience in audits and inspections.
• Degree in Biomedical Engineering, Pharmacy, or related fields.
• Fluency in English; French is a plus.