Responsable Affaires Réglementaires - spécialiste produits combinés

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

Résumé du poste

A leading company in Paris is seeking a Senior Regulatory Affairs Consultant to support pharmaceutical and medical device clients. The role involves developing regulatory strategies, guiding projects, and ensuring compliance with EU and US regulations. The ideal candidate has significant experience in Regulatory Affairs and a relevant degree.

Qualifications

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

Responsabilités

• Developing and implementing regulatory strategies for drug-delivery devices.
• Managing communications with notified bodies and health authorities.

Connaissances

Proactivity

Adaptability

Continuous Learning

Formation

Degree in Biomedical Engineering

Degree in Pharmacy

Description du poste

Social network you want to login/join with:

col-narrow-left

Client:

Beyond Conception GmbH

Location:

Paris, France

Job Category:

Other

-

EU work permit required:

Yes

col-narrow-right

Job Reference:

6917754788302028832760

Job Views:

1

Posted:

15.05.2025

Expiry Date:

29.06.2025

col-wide

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. You will lead and guide various regulatory projects, providing expert advice on strategies, classifications, and pathways, collaborating closely with R&D teams to develop new products or manage existing ones. Your responsibilities include:

1. Developing 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 US (FDA, 510(k), PMA, NDA, BLA, ANDA).
3. Supporting R&D teams during development, from design control to quality management, ensuring compliance with standards and regulations.
4. Collaborating with internal stakeholders to prepare 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.

Your profile:

• You are proactive, independent, and passionate about regulatory projects.
• You thrive in dynamic environments and are adaptable to client needs.
• You are committed to continuous learning and professional development.

You possess:

• 8–12 years of experience in Regulatory Affairs and R&D related to drug-delivery devices and combination products under EU and US frameworks.
• Knowledge of Quality Management Systems for medical devices and combination products.
• Experience supporting R&D from development to technical documentation and submissions.
• Ability to manage projects and stakeholder relationships independently.
• Experience with audits and inspections by NB/FDA/NCA.
• Degree in Biomedical Engineering, Pharmacy, or related fields.
• Fluency in English; French is a plus.