Regulatory Affairs Manager – Product Safety Certifications

This is a fully remote position, open to applicants in Germany.

📋 Description

• European Regulatory Leadership: Oversee and revise the Technical File for CE marking in accordance with the Machinery Directive and Regulation (2006/42/EC, 2023/1230/EU), Pressure Equipment Directive (PED), and Low Voltage Directive (LVD), along with other relevant regulations.

• North American Compliance (US & Canada): Direct the certification process with Nationally Recognized Testing Laboratories (NRTL) to ensure adherence to OSHA safety standards and the National Electrical Code, as well as other local regulations.

• FCC & EMC Strategy: Oversee FCC Part 15 testing and certification to confirm that our high-frequency components do not disrupt sensitive MRI environments.

• Implementation and maintenance of SOPs (Standard Operating Procedures) in the electronic Quality Management System pertaining to Regulatory processes.

• Review and Approval of Labeling and Promotional materials such as manuals (Installation, User manual, etc.).

• Global Risk Management: Lead the risk assessment process (ISO 12100) concerning hazards related to worker safety in the operation of the machine.

• Applicable regulatory frameworks monitoring: Serve as the internal scout for emerging international laws, regulations, directives, and standards (such as IEC/EN 61010 series) along with their national deviations in the US and Asia.

• Design life cycle and change control: Collaborate with R&D, QA, and Operations to ensure regulatory compliance throughout all development stages, including lifecycle management through change control processes and post-deployment surveillance.

• Third-Party Liaison: Manage interactions and audits with notified bodies, NRTLs, and international regulatory agencies.

⛳️ Requirements

• Degree in Mechanical/Electrical Engineering, Physics, or Law, with a strong technical emphasis and/or proven experience.

• 5-10 years of experience in regulatory affairs or compliance engineering for capital scientific equipment (e.g., lab automation, industrial machinery, or complex scientific instruments).

• EU expertise: Demonstrated success in securing applicable directives and driving the CE marking process while managing internal documentation and technical files.

• US Expertise: Proven ability to secure NRTL marks and navigate OSHA requirements and related authorizations.

• Capacity to interpret complex technical documentation, including electrical schematics and P&IDs, to assist in validating safety architectures and regulatory compliance alongside the engineering team.

• Hands-on experience and drive to establish a comprehensive regulatory process from the ground up as an entrepreneur.

• Knowledge of APAC regulations is an advantage.

• Basic understanding of Medical Device regulations in the EU and US is a plus.

• Professional fluency in English is essential; proficiency in German is a significant asset for local coordination.

🏝️ Benefits

• Attractive compensation package, including a competitive base salary and stock options.

• Key role in a highly advanced and rapidly growing startup company.

• Impactful product that enhances understanding and treatment of cancer.

• International team comprising over 30 different nationalities.

• Positive work environment characterized by open communication and a collaborative mindset.

• Option for remote or hybrid working model.

• Indefinite employment contract.

• 30 vacation days.

• Flexible working hours.

• Annual health budget (Allianz bKV).

• EGYM Wellpass.