Regulatory Affairs Manager – Product Safety Certifications

Role Overview

• As our Regulatory Affairs Manager, you will be the primary architect of our global compliance strategy.
• Ensure that POLARIS can be legally and safely installed in leading research hospitals and laboratories from Heidelberg to Houston and Tokyo.
• Move beyond "just paperwork," working hand-in-hand with R&D to design safety into the product from day one.
• 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.
• 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.
• APAC regulation knowledge is a plus
• Basic understanding of Medical Device regulations in the EU and US is a plus.
• Professional fluency in English is mandatory; German is a strong asset for local coordination.

Benefits

• Attractive compensation package, including a competitive base salary and stock options
• Key role in a highly advanced and fast-growing startup company
• Impactful product promoting better understanding and treatment of cancer
• International team, from over 30 different nationalities
• Positive work environment with open communication and a collaborative mindset
• Remote or Hybrid working model possible
• Indefinite employment contract
• 30 vacation days
• Flexible working hours
• Annual health budget (Allianz bKV)
• EGYM Wellpass