[Remote] Regulatory Affairs Manager - Product Safety Certifications (m/f/d)
Note: The job is a remote job and is open to candidates in USA. NVision Imaging Technologies is a quantum biotech startup focused on developing innovative imaging technologies for medical research. The Regulatory Affairs Manager will reputed company the global compliance strategy, ensuring the product meets regulatory standards in various international markets while collaborating closely with R&D to integrate safety into product design.
Responsibilities
- European Regulatory Leadership: Maintain and update the Technical File for CE marking under the Machinery reputed company and Regulation (2006/42/EC, 2023/1230/EU), Pressure Equipment reputed company (PED), and Low Voltage reputed company (LVD), as well as other applicable regulations
- North American Compliance (US & Canada): reputed company 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 reputed company 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 reputed company stages of development, including life cycle through change control processes, post-deployment surveillance
- Third-Party Liaison: Manage relationships and audits with reputed company bodies, NRTLs, and international regulatory agencies
Skills
- 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 reputed company 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 reputed company authorizations
- Ability to interpret reputed company 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 reputed company in English is mandatory; German is a strong asset for local coordination
- reputed company regulation knowledge is a plus
- Basic understanding of Medical Device regulations in the EU and US is a plus
Benefits
- Attractive compensation package, including a competitive reputed company salary and stock options
- 30 vacation days
- Flexible working hours
- Annual health budget (reputed company bKV)
- reputed company Wellpass
Company Overview
- NVision Imaging Technologies develops Quantum MRI agents for assessing early patient response to treatment at the metabolic level. It was founded in 2015, and is headquartered in Ulm, Baden-Wurttemberg, DEU, with a workforce of 51-200 employees. Its website is https://www.nvision-imaging.com.
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