Regulatory and Quality Manager, PointCaré

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Plaats

Gent
9000
Oost-Vlaanderen
België

Contract

Vooltijds, Onbepaalde duur

Datum gepubliceerd

2026-02-20

Online to:

2026-04-21
EUR 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

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