Responsable Affaires Réglementaires - spécialiste produits combinés

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

Résumé du poste

A leading company in the pharmaceutical sector seeks a Senior Consultant to guide clients in regulatory affairs for drug-delivery devices. The role involves developing strategies, managing projects, and ensuring compliance with EU and US regulations. Ideal candidates will have extensive experience in regulatory affairs, strong project management skills, and a degree in a relevant field.

Qualifications

• 8-12 years of experience in Regulatory Affairs or R&D for drug-delivery devices.
• Fluent in English; French is a plus.

Responsabilités

• Developing regulatory strategies for drug-delivery devices.
• Preparing regulatory dossiers and managing communications with authorities.
• Mentoring team members and contributing to internal training.

Connaissances

Regulatory Affairs

Project Management

Stakeholder Management

Quality Management Systems

Audits

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 involves leading regulatory projects, advising on strategies, classifications, and pathways, and collaborating 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 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 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 compliance with standards and regulations.
4. Preparing and reviewing regulatory dossiers and technical documentation.
5. Managing communications with notified bodies and health authorities, including audits and inspections.
6. Mentoring team members and contributing to internal training.

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 for medical devices and combination products.
• Experience with device development, design controls, and technical standards.
• Ability to manage multiple projects and stakeholder relationships independently.
• Proven experience with audits and inspections.
• Degree in Biomedical Engineering, Pharmacy, or related fields.
• Fluent in English; French is a plus.