Global Regulatory & Quality Lead — Medical Devices

TheOTCLab (B Corp™); Amsterdam; On-site; EUR 80,000 - 100,000; Full time

Benefits offered by this job

Competitive salary depending on experience

Purpose-driven company with B Corp values

Creative and sustainable office environment

Team events and international exposure

Job summary

A fast-growing health company in Amsterdam is seeking a Regulatory & Quality Compliance Manager. This role involves ensuring compliance with EU MDR and FDA regulations, maintaining ISO 13485 standards, and leading product registrations. Ideal candidates will have over 5 years of experience in Regulatory Affairs or Quality Assurance and a relevant degree. The position offers a competitive salary, a purpose-driven environment, and opportunities for personal growth.

Qualifications

• 5+ years of experience in Regulatory Affairs and/or Quality Assurance for medical devices.
• Strong knowledge of EU MDR and global registration procedures.
• Experience with technical documentation and CE-marking.

Responsibilities

• Ensure compliance with EU MDR, FDA and other applicable regulations.
• Develop and maintain technical documentation (CE dossiers, clinical evaluation, risk files).
• Maintain and improve our ISO 13485 and MDSAP-certified quality management system.

Skills

Regulatory Affairs

Quality Assurance

ISO 13485

EU MDR

Excellent communication skills in English

Education

Bachelor’s or master’s degree in sciences, medical technology, pharmacy, or related fields

Job description

A fast-growing health company in Amsterdam is seeking a Regulatory & Quality Compliance Manager. This role involves ensuring compliance with EU MDR and FDA regulations, maintaining ISO 13485 standards, and leading product registrations. Ideal candidates will have over 5 years of experience in Regulatory Affairs or Quality Assurance and a relevant degree. The position offers a competitive salary, a purpose-driven environment, and opportunities for personal growth.