Global QA & Regulatory Affairs Manager, Medical Devices

TheOTCLab (B Corp™); Amsterdam; On-site; EUR 70,000 - 110,000; Full time

Benefits offered by this job

Competitive salary

Purpose-driven company

Central Amsterdam office

International exposure

Job summary

TheOTCLab is seeking a Quality Assurance & Regulatory Affairs Manager to lead our quality systems and manage international registrations as we scale globally.

You will work hands-on with ISO 13485, MDSAP, EU MDR and CE documentation, coordinating with R&D, manufacturing and regulatory consultants to ensure compliant products across Europe, Australia, USA and beyond. This role blends execution with strategy in a dynamic Amsterdam setting.

Qualifications

• Bachelor's or master's in sciences, medical technology, pharmacy, or related field.
• 3–5 years in Quality Assurance and/or Regulatory Affairs for medical devices.
• Working knowledge of ISO 13485 and EU MDR; willingness to learn international registrations.
• Experience with technical documentation and CE marking.
• Excellent English communication; Dutch is a bonus.
• Accurate, structured, and organized, able to juggle several dossiers.

Responsibilities

• Manage and improve our ISO 13485 and MDSAP quality management system.
• Run internal audits, track CAPAs, and drive continuous improvement.
• Ensure lifecycle compliance from development to distribution.
• Coordinate with manufacturing on quality standards and documentation.
• Maintain EU MDR, FDA and other registrations and manage post-market surveillance.

Skills

Quality Assurance

Regulatory Affairs

Medical devices

CE marking

ISO 13485

EU MDR

Technical documentation

English communication

Dutch (bonus)

Education

Bachelor's or Master's in sciences/medical tech/pharmacy

Job description

TheOTCLab is seeking a Quality Assurance & Regulatory Affairs Manager to lead our quality systems and manage international registrations as we scale globally.

You will work hands-on with ISO 13485, MDSAP, EU MDR and CE documentation, coordinating with R&D, manufacturing and regulatory consultants to ensure compliant products across Europe, Australia, USA and beyond. This role blends execution with strategy in a dynamic Amsterdam setting.