Responsable Affaires Réglementaires - spécialiste produits combinés

JR France; Saint-Étienne; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A leading company in the pharmaceutical sector is seeking a Senior Consultant in Regulatory Affairs. The role involves guiding regulatory projects for drug-delivery devices, collaborating with R&D teams, and ensuring compliance with EU and US regulations. Ideal candidates will have extensive experience in regulatory frameworks and quality management systems, alongside strong project management skills. This position offers an opportunity to mentor team members and contribute to high-quality outcomes in a dynamic environment.

Qualifications

• 8-12 years of experience in Regulatory Affairs and/or R&D.
• Experience with Quality Management Systems.
• Proven experience in handling audits and inspections.

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

Project Management

Stakeholder Management

Regulatory Strategy

Quality Management

Collaboration

Formation

University degree in Biomedical Engineering

Pharmacy

Health Technology

Medical Science

Outils

ISO 13485

MDR

21 CFR 820

ISO 14971

Description du poste

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 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. Your responsibilities include:

1. Leading 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. Collaborating 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 sharing knowledge through 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. Your qualifications include:

• 8-12 years of relevant experience in Regulatory Affairs and/or R&D related to drug-delivery devices and/or combination products under EU and US frameworks.
• Experience with Quality Management Systems (ISO 13485, MDR, 21 CFR 820, ISO 14971).
• Expertise in device development under design controls and technical standards.
• Ability to manage projects and stakeholder relationships independently, leading regulatory strategies for multiple clients.
• Experience working cross-functionally with RA CMC, Manufacturing, Clinical, and Commercial teams.
• Proven experience in handling audits and inspections by NB, FDA, or NCA.
• University degree in Biomedical Engineering, Pharmacy, Health Technology, Medical Science, or relevant field.
• Fluency in English; French language skills are desirable.

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