Regulatory and Quality Manager
Solliciteren
Plaats
Gent9000
Oost-Vlaanderen
België
Contract
Vooltijds, Onbepaalde duurDatum gepubliceerd
2026-02-20Online to:
2026-04-21EUR 15.00 HOUR
Regulatory and Quality Manager
- PointCaré
- Oost-Vlaanderen
- 15 uren geleden
We are looking for a Regulatory Affairs Manager to lead regulatory strategy for our AI-driven Software as a Medical Device (SaMD) products. In this hands-on role, you'll enable fast, compliant innovation in a start-up environment, working closely with engineering, data science, product, and quality teams.
You'll take ownership of global regulatory activities, from early strategy through market approval and post-market compliance.
Role Description
Own and execute the regulatory strategy for AI-based SaMD products
Lead CE marking under EU MDR and support FDA pathways (510(k), De Novo, Q-Sub)
Prepare and maintain technical documentation for software and AI components
Advise teams on regulatory expectations for AI/ML, including data, performance, bias, and model updates
Act as the primary contact for Notified Bodies and regulatory authorities
Support audits, inspections, and post-market activities (PMS, vigilance, PSUR)
Translate evolving AI regulations into practical guidance for agile development teams
Profile Description
5+ years of Regulatory Affairs experience in Medical Devices
Proven experience with Software as a Medical Device (SaMD)
Experience with AI/ML-based medical software
Strong knowledge of EU MDR and FDA regulations for medical software
Familiarity with IEC 62304, ISO 13485, ISO 14971 and software lifecycle standards
Comfortable working in a fast-paced start-up or scale-up environment
Excellent communication skills and fluent in English
Why Join Us
Shape regulatory strategy for cutting-edge AI healthcare products
High ownership and direct impact on product and company success
Work closely with founders, engineers, and data scientists
You'll take ownership of global regulatory activities, from early strategy through market approval and post-market compliance.
Role Description
Own and execute the regulatory strategy for AI-based SaMD products
Lead CE marking under EU MDR and support FDA pathways (510(k), De Novo, Q-Sub)
Prepare and maintain technical documentation for software and AI components
Advise teams on regulatory expectations for AI/ML, including data, performance, bias, and model updates
Act as the primary contact for Notified Bodies and regulatory authorities
Support audits, inspections, and post-market activities (PMS, vigilance, PSUR)
Translate evolving AI regulations into practical guidance for agile development teams
Profile Description
5+ years of Regulatory Affairs experience in Medical Devices
Proven experience with Software as a Medical Device (SaMD)
Experience with AI/ML-based medical software
Strong knowledge of EU MDR and FDA regulations for medical software
Familiarity with IEC 62304, ISO 13485, ISO 14971 and software lifecycle standards
Comfortable working in a fast-paced start-up or scale-up environment
Excellent communication skills and fluent in English
Why Join Us
Shape regulatory strategy for cutting-edge AI healthcare products
High ownership and direct impact on product and company success
Work closely with founders, engineers, and data scientists