What are the responsibilities and job description for the Regulatory Affairs Professional position at Leica Biosystems?
We are seeking a highly skilled Regulatory Affairs Professional to join our team at Leica Biosystems. 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 Compliance: Ensure ongoing compliance with regulatory requirements through the preparation, review, and approval of regulatory documentation.
- Collaboration: Work closely with internal stakeholders, including cross-functional teams and external partners.
- Professional Development: Develop and maintain expertise in regulatory affairs, staying up-to-date with new and changing regulations.
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
