Responsable Affaires Réglementaires - spécialiste produits combinés

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

Résumé du poste

A leading company is seeking a Senior Regulatory Affairs Consultant to support pharmaceutical and medical device clients. The role involves leading regulatory projects, advising on strategies, and ensuring compliance with EU and US regulations. Ideal candidates will have extensive experience in Regulatory Affairs and strong collaboration skills.

Qualifications

• 8–12 years of experience in Regulatory Affairs or R&D related to drug-delivery devices.
• Strong cross-functional collaboration skills.

Responsabilités

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

Connaissances

Proactivity

Adaptability

Collaboration

Formation

Degree in Biomedical Engineering

Degree in Pharmacy

Outils

ISO 13485

MDR

21 CFR 820

ISO 14971

Description du poste

Client:

Beyond Conception GmbH

Location:

Not specified

Job Category:

Other

EU work permit required:

Yes

Job Reference:

69177547883020288327687

Job Views:

1

Posted:

15.05.2025

Expiry Date:

29.06.2025

Job Description:

As a Senior Regulatory Affairs (RA) Consultant, you will support pharmaceutical and medical device clients in developing, submitting, and managing drug-delivery devices and combination products throughout their lifecycle. Your role includes leading regulatory projects, advising on strategies, classifications, and pathways, and collaborating with R&D teams to develop or maintain products. You will ensure successful market entry and ongoing compliance in regions such as the EU and US.

Key responsibilities include:

1. Developing and implementing regulatory strategies for drug-delivery devices and combination products.
2. Providing guidance on classification and submission pathways (EU MDR, CE Marking; US FDA 510(k), PMA, NDA, BLA, ANDA).
3. Supporting R&D from design to quality management, ensuring compliance with standards and regulations.
4. Collaborating with internal teams to prepare regulatory dossiers and technical documentation.
5. Managing communications with notified bodies and health authorities, including audits and inspections.
6. Mentoring colleagues and contributing to internal training.

Ideal candidates are proactive, adaptable, eager to learn, and possess:

• 8–12 years of experience in Regulatory Affairs or R&D related to drug-delivery devices and combination products under EU and US regulations.
• Knowledge of Quality Management Systems (ISO 13485, MDR, 21 CFR 820, ISO 14971).
• Experience supporting R&D through development phases and managing regulatory projects independently.
• Strong cross-functional collaboration skills.
• Proven experience with audits and inspections.
• Degree in Biomedical Engineering, Pharmacy, or related fields.
• Fluency in English; French is a plus.

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