Regulatory Affairs Manager - Product Safety Certifications (m/f/d)

NVision Imaging Technologies is a quantum biotech startup innovating in metabolic imaging technology. They are seeking a Regulatory Affairs Manager to lead the global compliance strategy, ensuring that their product POLARIS meets regulatory requirements in various international markets while collaborating with R&D to integrate safety into product design.

Responsibilities:

• 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
• 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
• 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.)
• Own the risk assessment process (ISO 12100) for the hazards related to worker safety for the use of the machine
• 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
• 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
• Manage relationships and audits with notified bodies, NRTLs, and international regulatory agencies

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 (e.g., lab automation, industrial machinery, or complex scientific instruments)
• 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
• Ability to interpret complex technical documentation, including electrical schematics and P&IDs, to help validate safety architectures and regulatory compliance with the engineering team
• Hands on experience and motivation to build a great regulatory process from scratch as an entrepreneur
• Professional fluency in English is mandatory; German is a strong asset for local coordination
• APAC regulation knowledge is a plus
• Basic understanding of Medical Device regulations in the EU and US is a plus