Bachelor's degree in science, medical or technical field, or equivalent experience
5+ years of experience in medical device/IVD regulatory submissions
Knowledge of FDA (Class I & II) and Health Canada regulations
Familiarity with EU MDR/IVDR and related requirements
Experience with ISO 13485:2016 and FDA GMP standards
Background in Histopathology or Pathology field
Strong communication skills for interdisciplinary collaboration
Lean manufacturing tools knowledge, specifically Danaher Business Systems (DBS)
Responsibilities
Collaborate with cross-functional teams to launch IVD and laboratory products
Support global product registrations, listings, and renewals
Assist in new product development and regulatory compliance approvals
Prepare and review regulatory submissions like Technical Files and DoCs
Engage in active monitoring of regulatory changes and guidance
Review advertising materials for compliance with regulations
Explain complex regulatory information and assist during audits
Benefits
Onsite work environment in Richmond, Illinois
Opportunities for professional development in regulatory affairs
Involvement with cross-functional and international teams
Chance to enhance problem-solving skills in a dynamic field
Engagement in impactful product compliance initiatives
Full Job Description
Responsibilities:
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.
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 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
bility to travel - must be able to travel up to 10% of the time, (domestic and international)
