Responsable Affaires Réglementaires - spécialiste produits combinés

JR France; Montauban; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A leading company in the pharmaceutical sector is seeking a Senior RA Consultant to support clients in regulatory affairs for drug-delivery devices. The role involves developing regulatory strategies, collaborating with R&D, and mentoring team members. Ideal candidates will have extensive experience in regulatory frameworks and a strong commitment to quality outcomes.

Qualifications

• 8–12 years of experience in Regulatory Affairs and/or R&D related to drug-delivery devices.
• Experience with cross-functional collaboration and audits/inspections.

Responsabilités

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

Connaissances

Independent

Proactive

Knowledge of Quality Management Systems

Fluency in English

Cross-functional collaboration

Formation

University degree in Biomedical Engineering

Pharmacy

Health Technology

Medical Science

Description du poste

Client:

Beyond Conception GmbH

Location:

Montauban, France

Job Category:

Other

EU work permit required:

Yes

Job Reference:

69177547883020288327683

Job Views:

1

Posted:

15.05.2025

Expiry Date:

29.06.2025

Job Description:

As a Senior RA (Regulatory Affairs) 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 classification and submission pathways for the EU (MDR, CE Marking) and the US (FDA, 510(k), PMA, NDA, BLA, ANDA).
3. Supporting R&D in design control, quality management, and ensuring compliance with standards and regulations.
4. Collaborating with internal teams to prepare dossiers and technical documentation for submissions.
5. Managing communications with notified bodies and health authorities, including audits and inspections.
6. Mentoring team members and contributing to internal training.

Your Profile:

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 a strong commitment to professional development. 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 R&D through development phases of combination products.
• Ability to manage projects independently and lead regulatory strategies for multiple clients.
• Experience with cross-functional collaboration and audits/inspections.
• A university degree in Biomedical Engineering, Pharmacy, Health Technology, Medical Science, or related field.
• Fluency in English; French is desired.

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