Senior Manager, Regulatory Affairs | Senior Manager, Regulatory Affairs
FISHER SCIENTIFIC GmbH
Job Summary
Join Thermo Fisher Scientific as a Senior Manager of Regulatory Affairs, where you will play a crucial role in ensuring regulatory compliance across Europe for a diverse portfolio including medical devices, chemicals, and in-vitro diagnostics. This position involves developing and implementing regulatory policies aligned with EU regulations, leading projects to foster business growth, and mitigating regulatory risks. You will act as the primary liaison for European regulatory agencies and internal stakeholders, providing strategic guidance and ensuring all licenses and accreditations are current. The ideal candidate will have extensive experience in European and global regulatory affairs, particularly with IVDR, REACH, and CLP directives, and a strong background in leading complex, cross-functional regulatory projects.
Required Skills
Education
Bachelor’s degree or equivalent experience in Life Sciences, Chemistry, or Engineering. Equivalent combinations of education and experience focusing on regulatory project management and compliance expertise will be considered.
Experience
- Established proficiency in leading Regulatory Affairs at a senior level
- Experience handling complex projects and cross-functional teams
- Extensive knowledge of European regulatory requirements for medical devices, chemicals, and in-vitro diagnostics (IVDR)
- Extensive global regulatory affairs experience, including expertise in European and international chemical regulations, IVDR compliance, and directives like REACH and CLP
- Proven experience in Regulatory Affairs, particularly in Europe, with a strong background in leading chemical regulations and IVDR compliance
- Experience in leadership of cross-functional regulatory projects and implementation of global regulatory strategies
Languages
Additional
- Not specified
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