Responsable Affaires Réglementaires - spécialiste produits combinés

JR France; Le Plessis-Robinson; 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 strategies, guiding submissions, and collaborating with R&D teams. Ideal candidates will have extensive experience in regulatory frameworks and a commitment to quality outcomes.

Qualifications

• 8–12 years of experience in Regulatory Affairs related to drug-delivery devices.
• Knowledge of ISO 13485, MDR, 21 CFR 820.

Responsabilités

• Leading regulatory strategies for drug-delivery devices.
• Providing guidance on EU and US submission pathways.
• Mentoring team members and contributing to internal training.

Connaissances

Regulatory Affairs

Project Management

Stakeholder Management

Communication

Formation

University degree in Biomedical Engineering

Pharmacy

Outils

Quality Management Systems

Description du poste

Client:

Beyond Conception GmbH

Location:

Job Category:

Other

-

EU work permit required:

Yes

Job Reference:

69177547883020288327675

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 existing ones. Your responsibilities include:

1. Leading and implementing regulatory strategies 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 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 team members and contributing to internal training.

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. You possess:

• 8–12 years of experience in Regulatory Affairs and/or R&D related to drug-delivery devices and combination products under EU and US frameworks.
• Knowledge of Quality Management Systems (ISO 13485, MDR, 21 CFR 820, ISO 14971).
• Experience supporting development phases of combination products.
• Ability to manage projects and stakeholder relationships independently.
• Experience with audits and inspections by NB, FDA, or NCA.
• University degree in Biomedical Engineering, Pharmacy, or related fields.
• Fluency in English; French is a plus.