Your mission
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. You will move beyond "just paperwork," working hand-in-hand with R&D to design safety into the product from day one.
Key Responsibilities:
Who we are
NVision is a quantum biotech startup based in Ulm, Germany, with Tier 1 investors from Silicon Valley and Europe. We are just leaving stealth mode, moving from R&D to global commercialization and expansion.
Supported by top-tier venture capital from Silicon Valley and Europe, our groundbreaking product, POLARIS, facilitates imaging of real-time metabolism using standard MRI in combination with our quantum based hardware and in combination with in-house developed software tools, for both preclinical and clinical research. This innovation holds transformative potential across various medical fields, including oncology, cardiology, and neurology. Specifically, our technology can be leveraged to image tumor metabolism, providing clinicians with early, metabolic-level insights into treatment efficacy. This allows for a quicker shift in therapeutic strategies for non-responders, moving away from the slower anatomical assessments used in traditional imaging. Building on successful implementations at premier clinical sites, we are now executing our global commercial strategy to bring our technology to a wider market.
POLARIS is a high-tech mechatronic machine. It isn’t a medical device itself, but an innovative laboratory instrument involving high-pressure gas and fluids, precision electronics, mechanical automation, and magnetic field management. To scale globally, we need a regulatory expert who can navigate the intersection of European CE marking, North American NRTL/FCC requirements, and APAC standards.
Key Responsibilities:
- European Regulatory Leadership: Maintain and update the Technical File for CE marking under the Machinery Directive and Regulation (2006/42/EC, 2023/1230/EU), Pressure Equipment Directive (PED), and Low Voltage Directive (LVD), as well as other applicable regulations
- North American Compliance (US & Canada): Lead the certification process with Nationally Recognized Testing Laboratories (NRTL) to ensure compliance with OSHA safety standards and the National Electrical Code, as well as other applicable local regulations. FCC & EMC Strategy: Manage FCC Part 15 testing and certification to ensure our high-frequency components do not interfere with sensitive MRI environments.
- Implementation and maintenance of SOPs (Standard Operating Procedures) in the electronic Quality Management System which are relating to Regulatory processes.
- Review and Approval of Labelling and Promotion materials such as manuals (Installation, User manual, etc.).
- Global Risk Management: Own the risk assessment process (ISO 12100) for the hazards related to worker safety for the use of the machine
- Applicable regulatory frameworks monitoring: Act as the internal scout for evolving international laws, regulations, directives, standards (such as IEC/EN 61010 series) and their national deviation in the US and Asia.
- Design life cycle and change control: Collaborate with R&D, QA and Operation to manage regulatory compliance during all stages of development, including life cycle through change control processes, post-deployment surveillance
- Third-Party Liaison: Manage relationships and audits with notified bodies, NRTLs, and international regulatory agencies.
Who we are
NVision is a quantum biotech startup based in Ulm, Germany, with Tier 1 investors from Silicon Valley and Europe. We are just leaving stealth mode, moving from R&D to global commercialization and expansion.
Supported by top-tier venture capital from Silicon Valley and Europe, our groundbreaking product, POLARIS, facilitates imaging of real-time metabolism using standard MRI in combination with our quantum based hardware and in combination with in-house developed software tools, for both preclinical and clinical research. This innovation holds transformative potential across various medical fields, including oncology, cardiology, and neurology. Specifically, our technology can be leveraged to image tumor metabolism, providing clinicians with early, metabolic-level insights into treatment efficacy. This allows for a quicker shift in therapeutic strategies for non-responders, moving away from the slower anatomical assessments used in traditional imaging. Building on successful implementations at premier clinical sites, we are now executing our global commercial strategy to bring our technology to a wider market.
POLARIS is a high-tech mechatronic machine. It isn’t a medical device itself, but an innovative laboratory instrument involving high-pressure gas and fluids, precision electronics, mechanical automation, and magnetic field management. To scale globally, we need a regulatory expert who can navigate the intersection of European CE marking, North American NRTL/FCC requirements, and APAC standards.