Regulatory Affairs Specialist – Drug-Device Integration

Mogi I/O : OTT/Podcast/Short Video Apps for you; Grenoble; Hybride; EUR 90 000 - 110 000; Plein temps

Résumé du poste

A leading regulatory affairs consulting firm in Grenoble seeks an Associate Director of Regulatory Affairs. This strategic position requires 10+ years of experience in regulatory affairs within pharmaceuticals or medical devices, strong leadership skills, and expertise in FDA and EU regulations. The role involves overseeing regulatory activities, supporting business expansion, and training cross-functional teams, with a compensation range of EUR 90,000 – 110,000 plus benefits.

Qualifications

• 10+ years of regulatory affairs experience within pharmaceutical, medical devices, or drug-device combination products.
• Strong expertise in FDA and EU regulations, GxP standards, and Quality System Regulation.
• Proven leadership and people management experience within RA functions.

Responsabilités

• Lead and develop a high-performing regulatory affairs team.
• Oversee regulatory activities for marketed products.
• Provide client-facing support to ensure business alignment.

Connaissances

Regulatory Affairs experience

Leadership

Project Management

Communication skills

Negotiation skills

Fluent in English

Formation

Master’s Degree in Life Sciences

PharmD, PhD, or Medical Training

Description du poste

Overview

We are seeking an Associate Director of Regulatory Affairs to join our Regulatory & Compliance division in Grenoble, France. This strategic leadership role focuses on ensuring regulatory compliance for drug-device combination products, providing regulatory support for marketed products, and driving customer excellence initiatives. The role requires close collaboration with cross-functional teams including Regulatory Affairs, R&D, and Quality to ensure global compliance, dossier preparation, and successful regulatory interactions.

Details

Work Type: Full Time (Onsite – 4 days/week at Grenoble Pont-de-Claix Office)

Experience Required: 10 – 15 Years

Compensation: EUR 90,000 – 110,000 + Bonus + Benefits (Fixed Package)

Visa/Work Status: EU Citizens / Existing Work Authorization only (No Visa Sponsorship)

Work Mode: Hybrid – Primarily Onsite with Occasional Travel.

Key Responsibilities

• Lead and develop a high-performing regulatory affairs team, fostering a solutions-oriented culture.
• Oversee regulatory activities for marketed products, ensuring compliance with EU, FDA, and international requirements.
• Provide client-facing support, ensuring business alignment and customer satisfaction.
• Supervise regulatory review of promotional materials for compliance with legal and regulatory standards.
• Train cross-functional teams on EU and US (FDA) regulations relevant to drug-device systems.
• Maintain regulatory dossiers and manage submissions with global regulatory authorities.
• Support business expansion through timely global regulatory approvals and product registration updates.
• Act as the primary liaison in regulatory negotiations and audits with health authorities.

Must-Have Requirements

• 10+ years of regulatory affairs experience within pharmaceutical, medical devices, or drug-device combination products.
• Strong expertise in FDA and EU regulations, GxP standards, and Quality System Regulation.
• Proven leadership and people management experience within RA functions.
• Demonstrated ability to prepare regulatory submissions and interact effectively with authorities.
• Strong project management, negotiation, and communication skills.
• Fluent in English (French proficiency preferred).

Nice-to-Have Skills

• Experience with global dossier maintenance and lifecycle management.
• Previous exposure to customer-facing RA roles with a business orientation.
• Background in process improvement and change management initiatives.
• Knowledge of clinical trial regulations (GCP/GLP).

Education Requirements

• Minimum: Master’s Degree in Life Sciences, Pharmacy, Engineering, Chemistry, or related field.
• Preferred: Advanced degree (PharmD, PhD, or Medical Training).