The Regulatory Affairs Specialist is responsible for working with cross-functional teams to bring IVD (In-Vitro Diagnostic), Research (RUO) and Laboratorial products to market and support activities related to Quality Management System (QMS) to ensure ongoing compliance while continuing to develop regulatory affairs skills.
This position reports to the Director, Quality Assurance and Regulatory Compliance (Management Representative) and is part of the Regulatory Compliance team located in Richmond, Illinois and will be onsite.
Support product registrations, listings, and renewals globally with the support of Leica partners, and directly in US, 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 connected to regulatory compliance, using strong problem solving and decision-making skills.
Prepare, review, and approve regulatory documentation for submission, including but not limited to Technical Files and DoCs to regulatory agencies or to commercial partners, and advise on the submission strategy.
Control new and change legislations related to Regulatory Affairs activities, actively participating in committees and meetings to discuss new guidance including identifying relevant guidance documents, or consensus standards and providing interpretive assistance.
Review and approve Advertising and Promotional Materials (MAPSS) to ensure compliance with regulations in country/countries where materials are distributed, and explain complex information and respond to relevant questions raised during audits.
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 listing, regulatory requirements, Importer and Authorized Representative actions.
Experience with ISO 13485:2016, IVD/MDR Regulations, FDA GMP and domestic/international Medical Device Regulations.
Histopathology / Pathology field.
Demonstrated strong communication and collaboration skills across technical and non-technical teams.
Using lean manufacturing tools including Danaher Business Systems (DBS) tools to improve quality, processes, and innovation by applying tools and continuous improvement mind-set.
Ability to travel - must be able to travel up to 10% of the time, (domestic and international).
Regulatory Affairs Specialist • Charlotte, NC, United States
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