Regulatory & Quality Compliance Manager

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

Job Summary

Help us raise the standard for safe and accessible self‑care. At TheOTCLab, we create smart, safe, and science‑backed over‑the‑counter (OTC) healthcare products. With our entrepreneurial mindset and international outlook, we’re redefining what responsible consumer health looks like. We’re looking for a Regulatory & Quality Compliance Manager to take responsibility for our quality systems and regulatory strategy as we expand our footprint across global markets.

Who We Are

TheOTCLab is a fast‑growing health company based in Amsterdam. We make 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). Our goal: to give people easy access to safe, natural, and effective self‑care solutions.

Most of our products are already MDR certified, and we hold both ISO 13485 and MDSAP certifications. These standards reflect our commitment to quality and compliance with global market requirements, helping us stay ahead of evolving regulatory requirements.

We’re proud to be:

• Multiple FD Gazellen Award winner, ranked among the fastest‑growing companies in the Netherlands
• B Corp certified company, meeting the highest standards for social and environmental impact
• A compact, entrepreneurial international team on a shared mission to improve global self‑care
• Working from a creative and collaborative office centrally in Amsterdam
• Active in 50+ countries and growing fast — with both own brands and third‑party distribution

The Nature of the Role

This is a hands‑on role — ideal for someone who thrives in a fast‑paced environment and is ready to take end‑to‑end ownership of compliance execution. While you’ll be the internal lead, you’ll work closely with product, clinical, and commercial teams, and be supported by an established external regulatory consultancy to ensure high‑quality execution and strategic alignment.

Your Responsibilities

Regulatory Affairs (RA)

• Ensure compliance with EU MDR, FDA and other applicable regulations
• Develop and maintain technical documentation (e.g., CE dossiers, clinical evaluation, risk files)
• Lead CE‑marking and product registration efforts
• Manage and execute global product registrations, ensuring alignment with local regulatory requirements in key markets
• Serve as the primary contact for competent authorities and notified bodies
• Monitor and execute post‑market surveillance (PMS), vigilance, and incident reporting

Quality Assurance (QA)

• Maintain and improve our ISO 13485 and MDSAP‑certified quality management system (QMS)
• Lead internal audits, manage CAPAs, and drive continuous improvement
• Ensure compliance across product lifecycle, from development to distribution
• Collaborate with manufacturing partners to ensure high‑quality standards and documentation

Cross‑Functional Impact

• Work closely with R&D, supply chain, marketing, and product teams
• Guide the team in understanding regulatory frameworks and building compliant processes
• Train colleagues and promote a quality‑first mindset company‑wide

Who We’re Looking For

You’re both a strategic thinker and a doer. You know your way around MDR and ISO 13485 but enjoy translating frameworks into real‑world execution. You are organized, thorough, and customer‑centric — but also fast. You work with a sense of urgency and clarity, knowing how to balance regulatory depth with business speed. You want your work to make a difference – not just in systems, but in people’s lives.

Must‑Haves

• Bachelor’s or master’s degree in sciences, medical technology, pharmacy, or related fields
• 5+ years of experience in Regulatory Affairs and/or Quality Assurance for medical devices
• Strong knowledge of EU MDR, global registration procedures, ISO 13485, MDSAP, or FDA 21 CFR Part 820
• Experience with technical documentation and CE‑marking
• Excellent communication skills in English (Dutch is a bonus)
• Hands‑on, structured, proactive, and comfortable working independently, with the speed and responsiveness that fits a scale‑up environment

What We Offer

• Competitive salary depending on experience.

• A purpose‑driven company with B Corp values at the core.

• A work environment in a creative and sustainable office.

• A small and tight‑knit team that values autonomy, creativity, and impact.

• Team events, international exposure, and plenty of room to grow and develop yourself.

Ready to Make an Impact?

If you’re excited about bringing real innovation and quality to consumer healthcare, send your CV and motivation to [e-mail].

No recruiters please — we’ve got this.