Leica Biosystems
The Sr Manager, Quality and Regulatory Operations leads regulatory and quality operations to ensure compliance, market access, and commercial success for medical device products. This role partners with cross-functional teams to support tender readiness, implement UDI frameworks, and maintain robust Quality Management Systems. The position requires expertise in EU MDR, EUDAMED, and global regulatory frameworks to drive operational excellence and audit readiness.
Leica Biosystems is a global leader in workflow solutions and automation, integrating each step in the workflow from biopsy to diagnosis.
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
View leadership team, funding history,
and employee contacts for Leica Biosystems.
Leica Biosystems didn’t post a salary, so this is our estimate from similar listings.
Principal Regulatory Affairs Specialist, Labeling (SWICC)
Jobgether
Regulatory Affairs Officer – MDR & Technical Documentation
3ECRUIT
Principal Global Regulatory Affairs Specialist
Pulse Biosciences
Global Business Process Lead UDI
Ambu AS
Senior Regulatory Affairs Specialist
Dentsply Sirona
Principal Regulatory Affairs Specialist, Labeling (SWICC)
Getinge