Responsable Affaires Réglementaires - spécialiste produits combinés

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

Résumé du poste

A leading company in the pharmaceutical sector is seeking a Senior Consultant in Regulatory Affairs. The role involves supporting clients in navigating the complexities of drug-delivery devices and combination products, ensuring compliance with EU and US regulations. The ideal candidate will have extensive experience in regulatory strategies, quality management, and cross-functional collaboration. This position offers a unique opportunity to lead projects and mentor team members in a dynamic environment.

Qualifications

• 8-12 years of experience in Regulatory Affairs or R&D.
• Knowledge of Quality Management Systems (ISO 13485, MDR, 21 CFR 820).

Responsabilités

• Developing regulatory strategies for drug-delivery devices.
• Preparing and reviewing dossiers and technical documentation.
• Managing communications with notified bodies and health authorities.

Connaissances

Regulatory Affairs

Collaboration

Quality Management

Formation

Degree in Biomedical Engineering

Degree in Pharmacy

Description du poste

Job Description:

As a Senior (RA) Consultant, you will support pharmaceutical and medical device clients in developing, submitting, and managing the lifecycle of drug-delivery devices and combination products. Your role will involve leading regulatory projects, advising on strategies and pathways, and collaborating with R&D teams to ensure compliance and successful market entry in regions like the EU and US.

Key responsibilities include:

1. Developing and implementing regulatory strategies for drug-delivery devices and combination products.
2. Providing guidance on classification and submission pathways (EU MDR, CE Marking; US FDA 510(k), PMA, NDA, BLA, ANDA).
3. Supporting R&D in design control and quality management to meet standards and regulations.
4. Preparing and reviewing dossiers and technical documentation for submissions.
5. Managing communications with notified bodies and health authorities, including audits and inspections.
6. Mentoring team members and sharing knowledge internally.

Your profile:

• 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 (ISO 13485, MDR, 21 CFR 820, ISO 14971).
• Experience in device development, cross-functional collaboration, and managing audits.
• Degree in Biomedical Engineering, Pharmacy, or related fields.
• Fluent in English; French is a plus.