Quality Assurance Regulatory Affairs Manager

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

At TheOTCLab we create smart, safe and science-backed over-the-counter healthcare products. We are adding a Quality Assurance & Regulatory Affairs Manager to manage our quality systems and international registrations as our footprint grows. Our products are registered across Australia, Japan, Mexico, the USA, Brazil and Europe, and keeping that portfolio current is the core of the role. This is a hands-on, execution-focused position: final responsibility for compliance stays with our leadership and an established external regulatory consultancy, while you manage and carry out the day-to-day work behind it.

Quality Assurance

• Manage and improve our ISO 13485 and MDSAP certified quality management system
• Run internal audits, follow up on CAPAs and drive continuous improvement
• Help ensure compliance across the product lifecycle, from development to distribution
• Liaise with manufacturing partners on quality standards and documentation
• Work day to day with R&D, supply chain, marketing and product, keeping colleagues informed on what the regulations require

Regulatory Affairs

• Keep our products compliant with EU MDR, FDA and other applicable regulations
• Prepare and maintain technical documentation, including CE dossiers, clinical evaluation and risk files
• Compile and track product registrations across Australia, Japan, Mexico, the USA, Brazil and Europe, keeping each market's requirements and timelines on schedule
• Manage day-to-day correspondence with competent authorities and notified bodies
• Manage post-market surveillance, vigilance and incident reporting

What you bring

• A bachelor's or master's in sciences, medical technology, pharmacy or a related field
• Around 3 to 5 years in Quality Assurance and/or Regulatory Affairs for medical devices
• Working knowledge of ISO 13485 and EU MDR, with the appetite to learn international registration procedures on the job
• Exposure to technical documentation and CE-marking
• Excellent communication in English; Dutch is a bonus
• Accurate, structured and organised, comfortable juggling several dossiers and deadlines at scale-up speed

About TheOTCLab

A fast-growing health company based in Amsterdam, making innovative OTC medical devices and health products for global distribution — including our hero products FungeX, for fungal nail treatment, and Dr. Yglo, for the removal of warts and skin tags. We are a certified B Corporation, a multiple FD Gazellen Award winner and active in 40+ countries, with registrations spanning Australia, Japan, Mexico, the USA, Brazil and Europe.

What we offer

A salary in line with your experience, a purpose-driven company with B Corp values at its core, a creative and sustainable office in central Amsterdam, a small tight-knit team that values autonomy and impact, and international exposure across six regulatory regions with real room to grow into a broader QA/RA role.