Responsable Affaires Réglementaires - spécialiste produits combinés

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

Résumé du poste

A leading company in the pharmaceutical sector is seeking a Senior RA Consultant to support clients in regulatory projects for drug-delivery devices. The role involves developing regulatory strategies, guiding submissions, and collaborating with R&D teams. The ideal candidate will have extensive experience in Regulatory Affairs, a strong understanding of quality management systems, and the ability to manage projects independently. Fluency in English is required, with French as a plus.

Qualifications

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

Responsabilités

• Leading regulatory strategy development for drug-delivery devices.
• Compiling dossiers and technical documentation for submissions.
• Managing communications with notified bodies and health authorities.

Connaissances

Regulatory Affairs

Project Management

Stakeholder Management

Quality Management Systems

Fluency in English

Formation

University Degree in Biomedical Engineering

University Degree in 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 the lifecycle of existing ones. Your responsibilities 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 from design control to quality management, ensuring compliance with standards and frameworks.
4. Compiling dossiers and technical documentation for regulatory submissions.
5. Managing communications with notified bodies and health authorities, including audits and inspections.
6. Mentoring colleagues and contributing to internal training and development.

Candidate Profile:

You are an independent, proactive professional passionate about regulatory projects, thriving in dynamic environments, and committed to professional growth. You possess:

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