Head of Regulatory Affairs - Medical devicesMichael Page

Our client is an international company specialized in medical devices.

• Mentor, train, and supervise Regulatory Affairs teams, ensuring effective collaboration with other departments.
• Monitor and interpret changes in international regulations.
• Develop and implement regulatory strategy aligned with the company's business objectives, in collaboration with other departments.
• Supervise the preparation and submission of registration files required for product market entry, ensuring compliance with international requirements.
• Establish and maintain effective relationships with competent regulatory authorities, representing the company during regulatory inspections and audits.
• Ensure product compliance with standards and regulations, collaborating closely with cross-functional teams.

• University degree in sciences, pharmacy, biology, or a related field.
• Significant experience in Regulatory Affairs (for the pharmaceuticals and/or medical devices sectors).
• Minimum 10 years of experience in a similar role.
• Knowledge of European and US regulations.
• Strong team management and communication skills.
• Ability to work independently and make strategic decisions.
• Proficiency in English and French, both written and spoken.