What are the responsibilities and job description for the Compliance and Quality Manager position at Leica Biosystems?
As a Regulatory Compliance Specialist at Leica Biosystems, you will contribute to the advancement of cancer diagnostics and improvement of lives. You will work closely with cross-functional teams to develop and implement regulatory strategies, ensuring ongoing compliance with regulatory requirements.
About the Team
The Regulatory Compliance team is dedicated to ensuring that our products meet the highest standards of quality and safety. We work closely with colleagues across the organization to develop and implement effective regulatory strategies.
Main Responsibilities
- Regulatory Strategy: Develop and implement regulatory strategies to ensure ongoing compliance with regulatory requirements.
- Document Control: Ensure accurate and up-to-date documentation of regulatory submissions, reviews, and approvals.
- Liaison with Stakeholders: Collaborate with internal stakeholders, including cross-functional teams and external partners.
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
