Responsable Affaires Réglementaires - spécialiste produits combinés

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

Résumé du poste

A leading company in the pharmaceutical sector is seeking a Senior Consultant in Regulatory Affairs. The role involves leading regulatory projects for drug-delivery devices, ensuring compliance with EU and US regulations. The ideal candidate will have extensive experience in Regulatory Affairs, project management, and quality systems, along with a strong educational background in relevant fields. Join a dynamic team and contribute to innovative regulatory solutions.

Qualifications

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

Responsabilités

• Leading regulatory strategy development for drug-delivery devices.
• Providing guidance on regulatory classification and submission pathways.
• Managing communications with notified bodies and health authorities.

Connaissances

Regulatory Affairs

Project Management

Stakeholder Management

Quality Management Systems

Fluency in English

Fluency in French

Formation

University degree in Biomedical Engineering

University degree in Pharmacy

University degree in Health Technology

University degree in Medical Science

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:

69177547883020288327622

Job Views:

2

Posted:

16.05.2025

Expiry Date:

30.06.2025

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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 a variety of 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 and will contribute significantly to the successful market entry and maintenance of combination products in key regulatory regions, including the EU and US.

Key responsibilities include:

1. Leading and implementing the 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 technical standards and regulatory frameworks.
4. Liaising with key internal stakeholders, including RA CMC, Manufacturing, Clinical Development, and Marketing, to compile dossiers and technical documentation for regulatory submissions.
5. Drafting/reviewing relevant device sections of eCTD modules (e.g., 3.2.R, 3.2.P.2) for combination products applications.
6. Managing communications with notified bodies and health authorities, including participation in audits and inspections.
7. Mentoring other consultants and sharing knowledge within the team, contributing to internal training and development.

Your Profile:

You are an independent and proactive professional with a passion for contributing to cutting-edge regulatory projects. You thrive in dynamic environments and are adept at adjusting to clients' needs while ensuring high-quality regulatory outcomes. You are eager to continually learn and share knowledge with both clients and internal teams, demonstrating a strong commitment to your professional development.

You possess:

• Min 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 regulatory frameworks.
• Experience with Quality Management Systems for medical devices and combination products (ISO 13485, MDR, 21 CFR 820/QSR/QMSR, ISO 14971).
• Solid expertise in device development under design controls and familiarity with technical standards applicable to drug-delivery devices.
• Experience supporting R&D teams through development phases of combination products.
• Ability to independently manage projects and stakeholder relationships, leading regulatory strategies for multiple clients.
• Experience working cross-functionally with RA CMC, Manufacturing, Clinical, and Commercial teams for technical documentation and submissions.
• Proven experience handling NB/FDA/NCA audits and inspections.
• University degree in Biomedical Engineering, Pharmacy, Health Technology, Medical Science, or a relevant field.
• Fluency in English (required) and French (desired).