The Risk Management and PMS Manager leads a team of Quality Associates to develop and maintain IVDR Risk Management and PMS files for MBD's product portfolios. You collaborate with multi-functional teams across six sites in the US and Europe, and serve as the main contact for division partners. The role ensures Risk Management and PMS file quality and adherence to SOPs and templates. A day in the Life:

Drive the development and maintenance of IVDR Risk Management and PMS files across MBD's culture media, AST, ID, and associated product portfolios.
Manage the program to ensure files are reviewed in line with regulatory requirements.
Set the direction and goals for the team, acting as the Divisional Lead and expert in Risk Management and PMS file creation.
Foster strong working relationships with colleagues in all locations to acquire information required for file compilation.
Ensure common standards for Risk Management and PMS files across all product groups and locations.
Manage and communicate progress to the Quality Director and other key collaborators, highlighting areas of risk and uncertainty.
Anticipate and raise issues that could impact compliance in a timely manner, offering solutions for consideration.
Champion process improvements in line with the company's PPI Business System.

Degree in a relevant field or equivalent experience.
Proven knowledge of Risk Management and Post Market Surveillance in the IVD or MD Industry.
Effective people management skills.
Excellent planning, time management, and adaptability.
Strong oral and written communication skills.
Microbiology product knowledge.

When you're part of Thermo Fisher Scientific, you'll do challenging work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.

We offer competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!