Regulatory Affairs Manager - Product Safety Certifications (Medtech)

TL;DR

Regulatory Affairs Manager - Product Safety Certifications (Medtech): Architect global compliance strategy for quantum biotech imaging hardware POLARIS with an accent on EU CE marking under Machinery Directive/PED/LVD, US/Canada NRTL/OSHA/FCC certifications, and APAC standards. Focus on risk assessments per ISO 12100, SOP implementation, technical file maintenance, and regulatory lifecycle management through R&D collaboration.

Location: Remote EU (remote or hybrid working model possible)

Company

Quantum biotech startup based in Ulm, Germany, backed by top-tier VC, developing POLARIS laboratory instrument for real-time metabolic imaging via standard MRI enhancement in oncology, cardiology, and neurology research.

What you will do

• Lead European regulatory compliance: maintain Technical Files for CE marking (Machinery Directive, PED, LVD).
• Drive North American certifications: NRTL for OSHA/NEC, FCC Part 15/EMC for high-frequency components.
• Implement and maintain SOPs in QMS for regulatory processes; review labeling and promotion materials.
• Own global risk management per ISO 12100 for machine hazards.
• Monitor international regulations (IEC/EN 61010) and national deviations in US/Asia.
• Collaborate with R&D/QA/Operations on design lifecycle, change control, and post-deployment surveillance.
• Liaise with notified bodies, NRTLs, and regulatory agencies.

Requirements

• Professional fluency in English (mandatory); German is a strong asset.
• Degree in Mechanical/Electrical Engineering, Physics, or Law with strong technical focus.
• 5-10 years in regulatory affairs/compliance for capital scientific equipment (lab automation, industrial machinery).
• Proven EU expertise in CE marking, directives, technical files.
• Proven US expertise in NRTL marks, OSHA requirements.
• Ability to interpret electrical schematics, P&IDs for safety validation.
• Hands-on experience building regulatory processes from scratch.

Nice to have

• APAC regulation knowledge.
• Basic understanding of EU/US Medical Device regulations.

Culture & Benefits

• International team from 30+ nationalities with open communication and collaboration.
• Attractive compensation with base salary and stock options.
• Indefinite employment contract, 30 vacation days, flexible hours.
• Annual health budget (Allianz bKV), EGYM Wellpass.
• Key role in fast-growing startup impacting cancer treatment.