Responsable Affaires Réglementaires - spécialiste produits combinés

JR France; Nîmes; Sur place; EUR 60 000 - 80 000; 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 developing regulatory strategies, ensuring compliance, and mentoring colleagues. Ideal candidates will have experience with drug-delivery devices and a relevant degree.

Qualifications

• Experienced in drug-delivery devices and combination products under EU and US frameworks.
• Fluent in English; French is a plus.

Responsabilités

• Develop and implement regulatory strategies for drug-delivery devices.
• Compile dossiers and technical documentation for submissions.

Connaissances

Independent

Proactive

Project Management

Stakeholder Relationships

Cross-Functional Collaboration

Formation

Degree in Biomedical Engineering

Degree in Pharmacy

Outils

Quality Management Systems

ISO 13485

MDR

21 CFR 820/QSR

ISO 14971

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:

69177547883020288327647

Job Views:

1

Posted:

15.05.2025

Expiry Date:

29.06.2025

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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. Your responsibilities include leading regulatory projects, advising on strategies and pathways, collaborating with R&D teams, and ensuring compliance for market entry and maintenance in key regions such as the EU and US. Key responsibilities:

1. Develop and implement regulatory strategies for drug-delivery devices and combination products.
2. Provide guidance on regulatory classifications and submission pathways for the EU (MDR, CE Marking) and US (FDA, 510(k), PMA, NDA, BLA, ANDA).
3. Support R&D teams during development, from design control to quality management, ensuring regulatory compliance.
4. Compile dossiers and technical documentation for submissions, liaising with stakeholders and notified bodies.
5. Manage communications with authorities, participate in audits and inspections.
6. Mentor colleagues and contribute to internal training.

Your profile:

• Independent, proactive, with a passion for regulatory projects.
• Experienced in drug-delivery devices and combination products under EU and US frameworks.
• Knowledge of Quality Management Systems (ISO 13485, MDR, 21 CFR 820/QSR, ISO 14971).
• Skilled in device development, technical standards, and cross-functional collaboration.
• Proven track record in managing projects and stakeholder relationships.
• Experience with audits and inspections.
• Degree in Biomedical Engineering, Pharmacy, or related field.
• Fluent in English; French is a plus.