Responsable Affaires Réglementaires - spécialiste produits combinés

JR France; Chalon-sur-Saône; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

A leading company is seeking a Senior Consultant in Regulatory Affairs to support pharmaceutical and medical device clients. The role involves leading regulatory projects, providing expert advice, and ensuring compliance with EU and US frameworks. The ideal candidate will have extensive experience in regulatory affairs, project management, and a strong commitment to quality outcomes.

Qualifications

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

Responsabilités

• Lead regulatory strategy development for drug-delivery devices.
• Provide guidance on regulatory classification and submission pathways.
• Mentor other consultants and contribute to internal training.

Connaissances

Regulatory Affairs

Project Management

Quality Management Systems

Collaboration

Formation

University degree in Biomedical Engineering

Pharmacy

Description du poste

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Client:

Beyond Conception GmbH

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

69177547883020288327682

Job Views:

1

Posted:

15.05.2025

Expiry Date:

29.06.2025

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Job Description:

As an RA (Senior) 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 regulatory strategies, classifications, and pathways, while collaborating closely with R&D teams to develop new products or manage the lifecycle of authorized ones. You will be responsible for end-to-end regulatory support, contributing significantly to the successful market entry and maintenance of combination products in key regions, including the EU and US.

Key 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 the development phase, from design control to quality management, ensuring compliance with applicable standards and frameworks.
4. Liaising with internal stakeholders to compile dossiers and documentation for regulatory 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 other consultants and contributing to internal training and development.

Your profile:

You are an independent, proactive professional passionate about regulatory projects, thriving in dynamic environments, and committed to high-quality outcomes. You are eager to learn and share knowledge, demonstrating strong professional development commitment.

Requirements include:

• 8–12 years of relevant experience in Regulatory Affairs and/or R&D related to drug-delivery devices and combination products under EU and US frameworks.
• Experience with Quality Management Systems for medical devices and combination products.
• Solid expertise in device development under design controls and technical standards.
• Experience supporting R&D through development phases of combination products.
• Ability to independently manage projects and stakeholder relationships.
• Cross-functional experience with RA CMC, Manufacturing, Clinical, and Commercial teams.
• Proven experience handling audits and inspections.
• University degree in Biomedical Engineering, Pharmacy, or related field.
• Fluency in English required; French preferred.