Regulatory Affairs Specialist

Responsibilities

• Work with cross-functional teams to bring IVD, Research (RUO), and Laboratory products to market and support QMS compliance.
• Support product registrations, listings, and renewals globally, with support from Leica partners and direct involvement in US, Canada, and EU markets.
• Participate in cross-functional and cross-site partnerships and execution for new products and change management.
• Review and approve design files for regulatory compliance during new product development, design changes, and sustainment projects.
• Prepare, review, and approve regulatory documentation for submission, including Technical Files and DoCs, and advise on submission strategies.
• Control new and change legislations related to Regulatory Affairs activities, participate in committees and meetings to discuss new guidance, and provide interpretive assistance.
• Review and approve Advertising and Promotional Materials (MAPSS) to ensure compliance with regulations in distributed countries, and respond to audit-related questions.

Requirements

• Bachelor's degree in science, medical, or technical field or equivalent experience.
• Minimum of 5 years' experience within medical device/IVD, across a variety of regulatory submissions, compliance initiatives, and cross-functional projects.
• FDA (Class I & II) and Health Canada regulatory knowledge, including registration maintenance, device listings, regulatory requirements, and North America IVD regulatory intelligence.
• EU (MDR/IVDR) regulatory knowledge, including registration maintenance, device listings, regulatory requirements, Importer and Authorized Representative actions.
• Experience with ISO 13485:2016, IVD/MDR Regulations, FDA GMP, and domestic/international Medical Device Regulations.
• Demonstrated strong communication and collaboration skills across technical and non-technical teams.
• Ability to apply lean manufacturing tools like Danaher Business Systems (DBS) to improve quality, processes, and innovation.
• Must be able to travel up to 10% of the time, domestically and internationally.