Responsable Affaires Réglementaires - spécialiste produits combinés

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

Résumé du poste

A leading company in the pharmaceutical sector is seeking a Senior Regulatory Affairs Consultant to support clients in the development and management of drug-delivery devices. The role involves developing regulatory strategies, ensuring compliance, and mentoring team members. Ideal candidates will have extensive experience in Regulatory Affairs, project management skills, and a relevant university degree.

Qualifications

• 8-12 years of relevant experience in Regulatory Affairs and R&D.
• Experience with audits and inspections by NB, FDA, or NCA.

Responsabilités

• Developing and implementing regulatory strategies for drug-delivery devices.
• Preparing and reviewing technical documentation for regulatory submissions.
• Managing communications with notified bodies and health authorities.

Connaissances

Project Management

Stakeholder Management

Regulatory Affairs

Quality Management Systems

Device Development

Fluency in English

Formation

University Degree in Biomedical Engineering

University Degree in Pharmacy

University Degree in Health Technology

University Degree in Medical Science

Description du poste

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, while collaborating closely with R&D teams to develop new products or manage existing ones. Your responsibilities will include:

1. Developing and implementing regulatory strategies for drug-delivery devices and combination products.
2. Providing guidance on regulatory classifications and submission pathways for the EU (MDR, CE Marking) and the 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. Preparing and reviewing technical documentation and dossiers for regulatory submissions.
5. Managing communications with notified bodies and health authorities, including audits and inspections.
6. Mentoring team members and contributing to internal training and knowledge sharing.

**Your Profile:**

You are an independent, proactive professional passionate about regulatory projects, thriving in dynamic environments, and eager to learn and share knowledge. You should have:

• 8-12 years of relevant experience in Regulatory Affairs and R&D related to drug-delivery devices and combination products under EU and US frameworks.
• Experience with Quality Management Systems for medical devices and combination products.
• Solid expertise in device development under design controls and technical standards.
• Ability to manage projects and stakeholder relationships independently.
• Experience with audits and inspections by NB, FDA, or NCA.
• A university degree in Biomedical Engineering, Pharmacy, Health Technology, Medical Science, or related fields.
• Fluency in English; French language skills are a plus.