Responsable Affaires Réglementaires - spécialiste produits combinés

JR France; Tarbes; 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 the development and regulatory management of drug-delivery devices and combination products. The role involves leading regulatory strategies, collaborating with R&D teams, and ensuring compliance with EU and US regulations. Ideal candidates will have extensive experience in Regulatory Affairs, strong project management skills, and a commitment to high-quality outcomes.

Qualifications

• 8–12 years of relevant experience in Regulatory Affairs and 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

Formation

University degree in Biomedical Engineering

University degree in Pharmacy

Description du poste

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Client:

Beyond Conception GmbH

Location:

Job Category:

Other

EU work permit required:

Yes

Job Reference:

69177547883020288327688

Job Views:

1

Posted:

15.05.2025

Expiry Date:

29.06.2025

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 strategies, classifications, and pathways, while collaborating closely with R&D teams to develop new products or manage the lifecycle of existing ones. You will be responsible for end-to-end regulatory support, contributing to 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 from design control to quality management, ensuring compliance with standards and frameworks.
4. Liaising with internal stakeholders to compile dossiers and 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 team members 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, with a strong focus on professional development.

You possess:

• 8–12 years of relevant experience in Regulatory Affairs and 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 teams through development phases of combination products.
• Ability to manage projects and stakeholder relationships independently.
• Experience working cross-functionally to compile documentation and submissions.
• Proven experience in handling audits and inspections.
• University degree in Biomedical Engineering, Pharmacy, or related fields.
• Fluency in English; French is a plus.