What are the responsibilities and job description for the Regulatory Compliance Specialist position at Leica Biosystems?
At Leica Biosystems, we are committed to advancing cancer diagnostics and improving lives. As a key member of our Regulatory Compliance team, you will play a critical role in ensuring the company's ongoing compliance with regulatory requirements while developing our regulatory affairs capabilities.
About the Role
This position is responsible for working closely with cross-functional teams to bring IVD (In-Vitro Diagnostic), Research (RUO) and Laboratory products to market and support activities related to Quality Management System (QMS). The ideal candidate will have strong problem-solving and decision-making skills, as well as experience with ISO 13485:2016, IVD/MDR Regulations, FDA GMP and domestic/international Medical Device Regulations.
Main Responsibilities
- Regulatory Documentation: Prepare, review, and approve regulatory documentation for submission to regulatory agencies or commercial partners, and advise on the submission strategy.
- New Product Development: Support new product development, design change, and sustain projects by reviewing and approving design files connected to regulatory compliance.
- Legislative Updates: Control new and change legislations related to Regulatory Affairs activities, actively participating in committees and meetings to discuss new guidance.
- Advertising and Promotional Materials: Review and approve Advertising and Promotional Materials (MAPSS) to ensure compliance with regulations in country/countries where materials are distributed.
Requirements
To be successful in this role, you will need:
- A Bachelor's degree or minimum of 3 years equivalent experience
- Minimum of two years' experience within medical device/IVD
- 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
