Responsable Affaires Réglementaires - spécialiste produits combinés

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

Résumé du poste

A leading company in the pharmaceutical and medical device sector is seeking a Senior Regulatory Affairs Consultant. The role involves guiding regulatory projects, ensuring compliance, and collaborating with R&D teams on drug-delivery devices and combination products. Ideal candidates will have extensive experience in regulatory affairs, project management, and a strong educational background in relevant fields.

Qualifications

• 8-12 years of relevant experience in Regulatory Affairs and/or R&D.
• Experience with ISO 13485, MDR, 21 CFR 820.

Responsabilités

• Lead regulatory strategy development for drug-delivery devices.
• Provide guidance on EU and US regulatory pathways.

Connaissances

Leadership

Project Management

Communication

Formation

University degree in Biomedical Engineering

Pharmacy

Health Technology

Medical Science

Outils

Quality Management Systems

Description du poste

Client:

Beyond Conception GmbH

Location:

Job Category:

Other

-

EU work permit required:

Yes

Job Reference:

69177547883020288327681

Job Views:

1

Posted:

15.05.2025

Expiry Date:

29.06.2025

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. You will lead and guide various regulatory projects, providing expert advice on regulatory strategies, classifications, and pathways, while collaborating closely with R&D teams to develop new products or manage the lifecycle of authorized ones. 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, from design control to quality management, ensuring compliance with applicable standards and frameworks.
4. Liaising with internal stakeholders to compile dossiers and technical documentation for regulatory submissions.
5. Drafting and reviewing device sections of eCTD modules for combination products applications.
6. Managing communications with notified bodies and health authorities, including audits and inspections.
7. Mentoring other consultants and contributing to internal training and development.

Your profile:

You are an independent, proactive professional passionate about contributing to cutting-edge regulatory projects. You thrive in dynamic environments, are adaptable to client needs, and committed to high-quality outcomes. You are eager to learn and share knowledge with clients and teams.

Requirements include:

• 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 frameworks.
• Experience with Quality Management Systems (ISO 13485, MDR, 21 CFR 820, ISO 14971).
• Expertise in device development under design controls and technical standards.
• Ability to manage projects independently and lead regulatory strategies for multiple clients.
• Experience working cross-functionally to compile documentation and handle audits.
• University degree in Biomedical Engineering, Pharmacy, Health Technology, Medical Science, or related field.
• Fluency in English; French is desirable.