Regulatory Affairs Leader, Medical Devices

Approach People Recruitment; Niort; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

A recruitment agency in France is seeking a Head of Regulatory Affairs to lead a team focused on ensuring compliance for medical devices. The ideal candidate will have over 10 years of experience in regulatory affairs, along with a strong understanding of local and international regulations like FDA and EMA. Excellent leadership skills and proficiency in English and German are required, with French being a plus. This role involves managing regulatory submissions, strategic guidance, and collaboration with various departments.

Qualifications

• At least 10 years experience in regulatory affairs, preferably in medical devices.
• In-depth knowledge of local and international regulations related to medical devices.
• Proficiency in English and German, French is an advantage.

Responsabilités

• Manage and lead the regulatory affairs team.
• Develop and implement regulatory strategies for compliance.
• Ensure timely submission of regulatory filings.
• Evaluate regulatory requirements for new products.
• Manage interactions with regulatory agencies.
• Maintain regulatory surveillance for new developments.
• Collaborate with internal teams for compliance processes.
• Participate in internal and external audits.

Connaissances

Leadership

Regulatory Affairs Knowledge

Communication Skills

Team Management

Collaboration

Formation

University degree in life sciences or biomedical engineering

Description du poste

A recruitment agency in France is seeking a Head of Regulatory Affairs to lead a team focused on ensuring compliance for medical devices. The ideal candidate will have over 10 years of experience in regulatory affairs, along with a strong understanding of local and international regulations like FDA and EMA. Excellent leadership skills and proficiency in English and German are required, with French being a plus. This role involves managing regulatory submissions, strategic guidance, and collaboration with various departments.