Regulatory Specialist

The Regulatory Affairs Specialist works with cross‑functional teams to bring IVD (In‑Vitro Diagnostic), Research (RUO), and Laboratory products to market and supports activities related to the Quality Management System (QMS) to ensure ongoing compliance while continuing to develop regulatory affairs skills.

• Work with cross‑functional teams to bring IVD, RUO, and Laboratory products to market and support QMS activities to ensure compliance.
• Report to the Director of Quality Assurance and Regulatory Compliance (Management Representative) and be part of the Regulatory Compliance team.
• Support product registrations, listings, and renewals globally, especially in the U.S., Canada, and EU markets, requiring cross‑functional and cross‑site partnership and execution for new products and change management.
• Support new product development, design change, and sustainment projects by reviewing and approving design files that relate to regulatory compliance.
• Prepare, review, and approve regulatory documentation for submission, including Technical Files and Documents to regulatory agencies or commercial partners, and advise on the submission strategy.
• Control new and changing legislation related to Regulatory Affairs activities, actively participating in committees and meetings to discuss new guidance, identify relevant guidance documents or consensus standards, and provide interpretive assistance.
• Review and approve Advertising and Promotional Materials (MAPSS) to ensure compliance with regulations in all countries where materials are distributed, explain complex information, and respond to audit questions.

• Bachelor’s degree in science, medical, or technical field, or equivalent experience.
• Minimum of 2 years of 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 listing, regulatory requirements, importer and authorized representative actions.
• Experience with ISO 13485:2016, IVD/MDR regulations, FDA GMP, and domestic/international Medical Device Regulations in the Histopathology / Pathology field.
• Demonstrated strong communication and collaboration skills across technical and non‑technical teams.
• Proficiency with lean manufacturing tools, including Danaher Business Systems (DBS) tools to improve quality, processes, and innovation through continuous improvement mind‑set.
• Ability to travel: must be able to travel up to 10% of the time, domestically and internationally.
• Overnight travel may be required.