NVision Imaging Technologies

Regulatory Affairs Manager – Product Safety Certifications

NVision Imaging Technologies

full-time

Posted on:

Location Type: Remote

Location: Germany

Visit company website

Explore more

✨ AI Apply
Apply

About the role

  • 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
  • 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
  • Manage FCC Part 15 testing and certification to ensure high-frequency components do not interfere with sensitive MRI environments
  • Implementation and maintenance of SOPs (Standard Operating Procedures) in the electronic Quality Management System relating to Regulatory processes
  • Own the risk assessment process (ISO 12100) for hazards related to worker safety for the use of the machine
  • Act as the internal scout for evolving international laws, regulations, directives, standards 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
  • 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
  • 30 vacation days
  • Flexible working hours
  • Annual health budget (Allianz bKV)
  • EGYM Wellpass
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory affairscompliance engineeringCE markingNRTL certificationOSHA standardsrisk assessmentISO 12100technical documentation interpretationelectrical schematicsP&IDs
Soft Skills
collaborationleadershiporganizational skillscommunicationentrepreneurial mindset