Responsable Affaires Réglementaires - spécialiste produits combinés

JR France; Nantes; 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 strategy, managing submissions, and mentoring team members. Ideal candidates will have extensive experience in regulatory affairs related to drug-delivery devices and a strong educational background in biomedical engineering or pharmacy.

Qualifications

• 8–12 years of relevant experience in Regulatory Affairs and R&D.
• Experience with Quality Management Systems.

Responsabilités

• Leading regulatory strategy development for drug-delivery devices.
• Managing communications with notified bodies and health authorities.

Connaissances

Regulatory Affairs

Project Management

Stakeholder Management

Formation

Biomedical Engineering

Pharmacy

Outils

ISO 13485

MDR

21 CFR 820

ISO 14971

Description du poste

The provided job description is comprehensive and well-structured, but it can be improved for clarity and readability by properly utilizing HTML tags and removing redundant or irrelevant information. Here is a refined version:

Job Title: Senior Regulatory Affairs (RA) Consultant

Location: [Specify Location]

Client: Beyond Conception GmbH

Job Category: Online Job Hunting Tools / Other

EU Work Permit Required: Yes

Job Reference: Online job hunting tools 6917754788302028832763

Job Views: 1

Posted: 15.05.2025

Expiry Date: 29.06.2025

Job Description

As a Senior Regulatory Affairs 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 and implementing regulatory strategy development for drug-delivery devices and combination products.
• Providing guidance on regulatory classification and submission pathways for the EU (MDR, CE Marking) and the US (FDA, 510(k), PMA, NDA, BLA, ANDA).
• Supporting R&D teams during development, from design control to quality management, ensuring compliance with applicable standards and regulations.
• Collaborating with internal stakeholders to compile dossiers and technical documentation for regulatory submissions.
• Drafting and reviewing device sections of eCTD modules for applications.
• Managing communications with notified bodies and health authorities, including audits and inspections.
• Mentoring team members and contributing to internal training and development.

Candidate Profile

You are an independent, proactive professional passionate about regulatory projects, adaptable to dynamic environments, and committed to high-quality outcomes. You should possess:

• 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 (ISO 13485, MDR, 21 CFR 820, ISO 14971).
• Familiarity with device development under design controls and technical standards.
• Ability to manage projects and stakeholder relationships independently.
• Proven experience handling audits and inspections.
• Educational background in Biomedical Engineering, Pharmacy, or related fields.
• Fluency in English; French is a plus.

Note: If you are not a passport holder of the country for the vacancy, a work permit may be required. Please refer to our Blog for more information.

All applications should be made via the 'Apply now' button. Do not provide bank or payment details when applying. Eurojobs.com is not responsible for external website content.