Responsable Affaires Réglementaires - spécialiste produits combinés

JR France; Saint-Denis; 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 Consultant to lead regulatory projects for drug-delivery devices. The role involves strategic development, compliance management, and collaboration with R&D teams. Ideal candidates will have extensive experience in Regulatory Affairs and a strong educational background in Biomedical Engineering or Pharmacy. Fluency in English is essential, with French being a plus.

Qualifications

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

Responsabilités

• Leading regulatory strategy development for drug-delivery devices.
• Providing guidance on regulatory classification and submission pathways.
• Managing communications with notified bodies and health authorities.

Connaissances

Regulatory Affairs

Project Management

Stakeholder Management

Compliance

Formation

University degree in Biomedical Engineering

Pharmacy

Description du poste

Job Description:

As a Senior (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. Leading 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 during development, ensuring compliance with standards and regulations.
4. Collaborating with internal stakeholders to compile dossiers and documentation for submissions.
5. Drafting and reviewing device sections of eCTD modules for applications.
6. Managing communications with notified bodies and health authorities, including audits.
7. 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 strong professional development. You possess:

• 8–12 years of experience in Regulatory Affairs or R&D related to drug-delivery devices and combination products under EU and US regulations.
• Knowledge of Quality Management Systems for medical devices.
• Experience supporting R&D teams through development phases.
• Ability to manage projects and stakeholder relationships independently.
• Experience with audits and inspections.
• University degree in Biomedical Engineering, Pharmacy, or related fields.
• Fluency in English; French is a plus.