Responsable Affaires Réglementaires - spécialiste produits combinés

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

Résumé du poste

A leading company in the pharmaceutical and medical device sector seeks a Senior Regulatory Affairs Consultant. This role involves leading regulatory projects, ensuring compliance with EU and US regulations, and collaborating with R&D teams. The ideal candidate will have extensive experience in regulatory affairs, a relevant degree, and a proactive approach to project management.

Qualifications

• 8–12 years of experience in Regulatory Affairs and R&D.
• Strong expertise in device development under design controls.

Responsabilités

• Leading and implementing regulatory strategies for drug-delivery devices.
• Providing guidance on classification and submission pathways for EU and US.
• Managing communications with notified bodies and health authorities.

Connaissances

Regulatory Affairs

Project Management

Collaboration

Formation

Degree in Biomedical Engineering

Degree in Pharmacy

Degree in Health Technology

Degree in Medical Science

Description du poste

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. Your responsibilities include leading regulatory projects, providing expert advice on strategies, classifications, and pathways, and collaborating closely with R&D teams to develop new products or manage existing ones. You will ensure successful market entry and maintenance of products in key regions such as the EU and US.

Key responsibilities include:

1. Leading and implementing regulatory strategies for drug-delivery devices and combination products.
2. Providing guidance on classification and submission pathways for the EU (MDR, CE Marking) and US (FDA, 510(k), PMA, NDA, BLA, ANDA).
3. Supporting R&D teams during development, from design control to quality management, ensuring compliance with standards and regulations.
4. Liaising 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 and inspections.
7. Mentoring colleagues and contributing to internal training and development.

Your profile:

You are an independent, proactive professional passionate about regulatory projects. You thrive in dynamic environments, are adaptable to client needs, and committed to continuous learning and development. You possess:

• 8–12 years of experience in Regulatory Affairs and R&D related to drug-delivery devices and combination products.
• Experience with EU and US regulatory frameworks and quality management systems.
• Strong expertise in device development under design controls and technical standards.
• Proven ability to manage projects independently and lead regulatory strategies.
• Experience working cross-functionally with various teams and handling audits and inspections.
• Degree in Biomedical Engineering, Pharmacy, Health Technology, Medical Science, or a related field.
• Fluency in English; French is desirable.