Responsable Affaires Réglementaires - spécialiste produits combinés

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

Résumé du poste

A leading company in the pharmaceutical and medical device sector is seeking a Senior Regulatory Affairs Consultant. In this role, you will support clients in the development and lifecycle management of drug-delivery devices, ensuring compliance with EU and US regulations. You will lead strategy development, mentor team members, and manage communications with regulatory bodies. Ideal candidates will have extensive experience in Regulatory Affairs, a relevant degree, and a passion for continuous learning.

Qualifications

• 8–12 years of relevant experience in Regulatory Affairs and/or R&D.
• Experience with EU and US regulatory frameworks.

Responsabilités

• Leading and implementing regulatory strategy development.
• Managing communications with notified bodies and health authorities.

Connaissances

Project management

Stakeholder relationship management

Continuous learner

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:

69177547883020288327649

Job Views:

1

Posted:

15.05.2025

Expiry Date:

29.06.2025

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Job Description:

As a Senior Regulatory Affairs (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. 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, ensuring compliance with applicable standards and frameworks.
4. Collaborating with internal stakeholders to compile dossiers and technical 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 team members and contributing to internal training.

Your profile:

• Independent and proactive professional passionate about regulatory projects.
• Ability to adjust to client needs while ensuring high-quality outcomes.
• Continuous learner committed to professional development.

Qualifications include:

• 8–12 years of relevant experience in Regulatory Affairs and/or R&D related to drug-delivery devices and combination products.
• Experience with EU and US regulatory frameworks.
• Knowledge of Quality Management Systems for medical devices.
• Familiarity with device development under design controls and technical standards.
• Experience supporting R&D teams through development phases.
• Project management skills and stakeholder relationship management.
• Experience with audits and inspections.
• University degree in Biomedical Engineering, Pharmacy, or related fields.
• Fluency in English; French is a plus.