Regulatory Affairs Maanger

• Lead the regulatory strategy for new product introductions and support existing products through their full lifecycle.
• Manage regulatory submissions (e.g. 510(k), CE Mark) and global product registrations.
• Act as the primary contact for regulatory agencies, including authorities in the U.S. and Europe.
• Monitor and interpret evolving regulatory requirements and apply them to ensure company compliance.
• Partner with Quality Assurance to ensure post-market surveillance and vigilance activities meet applicable standards.
• Review and approve promotional and advertising materials from a regulatory perspective.
• Identify and allocate internal and external resources needed to maintain a robust regulatory function.
• Provide strategic advice and cross-functional support on all regulatory matters.

• Bachelor’s degree in Engineering, Life Sciences, or a health-related field.
• 10+ years of experience in the medical device industry, with a minimum of 3 years in a leadership or management role.
• In-depth knowledge of US FDA and EU medical device regulations (including MDR).
• Proven ability to handle complex regulatory submissions and interactions.
• Excellent organizational, leadership, and communication skills.
• A self-starter with a hands-on approach and the ability to thrive in a dynamic, entrepreneurial environment.
• Previous experience in an SME or medtech startup is highly desirable.

Life Science Recruitment