Regulatory Affairs Manager – Product Safety Certifications

🕒 March 27

🇩🇪 Germany – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✅ Product Manager

👻 Ghost score 46%

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NVision Imaging Technologies

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

NVision Imaging Technologies is pioneering advancements in quantum physics to facilitate the routine, cost-effective utilization of Magnetic Resonance Imaging (MRI) for evaluating early patient responses to cancer treatments at the metabolic level. By employing hyperpolarization, NVision enhances MRIs to efficiently measure natural metabolites, providing unprecedented cellular insights critical for assessing tumorous activity. Their technology, Polaris, is compact and straightforward, enabling metabolic MRI to be accessible in clinical and preclinical settings without significant infrastructure changes. This breakthrough allows for rapid, accurate differentiation between resistant and sensitive tumors soon after treatment begins, with potential applications extending beyond oncology into cardiology, hepatology, nephrology, neurology, and rheumatology. NVision is supported by deep-tech investors and collaborates with leading medical and research institutions across the US and EU.

📋 Description

• 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

🎯 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