Regulatory Affairs Manager - Product Safety Certifications (m/f/d)
NVision Imaging TechnologiesUlm, Baden-Württemberg, Germany
Posted February 17, 2026
Full Time
About the Company
NVision Imaging Technologies specializes in quantum-powered medical imaging technologies, offering advanced MRI solutions with its hyperpolarization device POLARIS. This technology enables faster, more precise cellular-level imaging across various medical fields, including oncology, cardiology, and neurology, enhancing diagnostic accuracy and treatment outcomes.
Job Description
As our Regulatory Affairs Manager, you will be the primary architect of our global compliance strategy. You will ensure that POLARIS can be legally and safely installed in leading research hospitals and laboratories from Heidelberg to Houston and Tokyo.
Requirements
- Degree in Mechanical/Electrical Engineering, Physics, or Law but with a strong technical focus and/or track record.
- 5-10 years in regulatory affairs or compliance engineering for capital scientific equipment.
- EU expertise: Proven track record in securing applicable directives and driving CE marking process, managing internal documentation and technical files
- US Expertise: Proven track record in securing NRTL marks and navigating OSHA requirements and related authorizations.
Benefits
- Attractive compensation package, including a competitive base salary and stock options
- 30 vacation days
- Flexible working hours
- Annual health budget (Allianz bKV)
- EGYM Wellpass
