Position Summary:

As a Regulatory Affairs Manager, you will be responsible for ensuring compliance with GCP/GMP and ISO 13485, as well as the regulatory aspects required by our technologies. You will be recognized as an expert by all, and will interface with all the company's departments.

Under the responsibility of the Head Pharmacist, your main tasks will be to:

• Prepare, guide project teams, review, and submit regulatory dossiers (IMPD, pre-IND, CE marking, etc.)
• Monitor the progress of submissions with Notified Bodies and Health Authorities
• Manage change control processes and regulatory intelligence activities
• Oversee vigilance activities (EMA Trusted Deputy backup)
• Manage interactions with Healthcare Professionals’ Councils (transparency declarations, agreements, etc.)
• Participate in internal and external audits and inspections
• Contribute to internal staff training
• If you are a pharmacist, a PRI role could also be considered in connection with this position.

Qualifications:

• Degree in Engineering, Pharmacy, or Master’s degree (MSc) with a regulatory specialization
• 3 to 5 years of experience in Regulatory Affairs for GMP and/or Medical Devices
• Autonomous, rigorous, and results-oriented with strong analytical and communication skills
• Excellent writing skills
• Fluent in English (written and spoken)
• Any knowledge of Advanced Therapy Medicinal Products (ATMPs) would be considered a strong asset.

What we offer:

• Permanent position (full-time contract) based in the city center of Mulhouse, with the possibility of remote work in accordance with the company’s internal policy
• Meal vouchers
• Profit-sharing bonus
• Employee savings plans
• A great working environment and excellent quality of life at work

If you would like to join a fast-growing startup with an international reach, where your boldness and commitment will truly make a difference, we would be delighted to receive your application!