Responsable Affaires Réglementaires - spécialiste produits combinés

JR France; Courbevoie; Sur place; EUR 65 000 - 85 000; Plein temps

Résumé du poste

A leading company in Courbevoie is seeking a Senior RA Consultant to support pharmaceutical and medical device clients. The role involves leading regulatory strategy, managing submissions, and ensuring compliance with EU and US regulations. Candidates should have extensive experience in Regulatory Affairs and a relevant degree. This position offers opportunities for professional growth and a dynamic work environment.

Qualifications

• 8–12 years of relevant experience in Regulatory Affairs or R&D.
• Fluent in English; French is a plus.

Responsabilités

• Lead regulatory strategy development for drug-delivery devices.
• Support R&D teams ensuring compliance with standards.
• Manage communications with notified bodies and health authorities.

Connaissances

Regulatory Affairs

Project Management

Quality Management Systems

Communication

Formation

Degree in Biomedical Engineering

Degree in Pharmacy

Degree in Health Technology

Degree in Medical Science

Description du poste

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Client:

Beyond Conception GmbH

Location:

Courbevoie, France

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

69177547883020288327629

Job Views:

1

Posted:

15.05.2025

Expiry Date:

29.06.2025

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Job Description:

As a Senior RA (Regulatory Affairs) 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:

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 in development phases, from design control to quality management, ensuring compliance with applicable standards and frameworks.
4. Liaising with internal stakeholders to compile dossiers and technical 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 knowledge sharing.

Your profile:

• You are proactive, independent, and passionate about regulatory projects.
• You thrive in dynamic environments and are adaptable to client needs while ensuring quality outcomes.
• You are eager to learn and share knowledge, committed to professional growth.

Requirements:

• 8–12 years of relevant experience in Regulatory Affairs or R&D related to drug-delivery devices and combination products.
• Experience with EU (MDR, CE Marking) and US (FDA, 510(k), PMA, NDA, BLA, ANDA) regulatory frameworks.
• Knowledge of Quality Management Systems (ISO 13485, MDR, 21 CFR 820/QSR, ISO 14971).
• Experience supporting R&D and managing projects independently.
• Ability to work cross-functionally and handle audits and inspections.
• Degree in Biomedical Engineering, Pharmacy, Health Technology, Medical Science, or relevant field.
• Fluent in English; French is a plus.