Job openings

Quality Assurance & Regulatory Affairs Manager

Amsterdam  |  OTC Medical Devices & Consumer Health  |  Full-time

Take our products to market, everywhere in the world

At TheOTCLab we create smart, safe and science-backed over-the-counter healthcare products. Most of them are already MDR certified, and we hold both ISO 13485 and MDSAP. The systems are in place and they work. What is growing fast is the international side: our products are registered across Australia, Japan, Mexico, the USA, Brazil and Europe, and there is now more day-to-day work than our current team can absorb. That is why we are creating this role.

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 is to give people easy access to safe, effective self-care solutions.
Most of our products are MDR certified and we hold both ISO 13485 and MDSAP certifications. These standards reflect our commitment to quality and to global market compliance.

We’re proud to be:

• A multiple FD Gazellen Award winner, ranked among the fastest-growing companies in the Netherlands
• A 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
• Registered and active in 40+ countries, from Australia and Japan to Mexico, the USA, Brazil and Europe

The nature of the role

This is a hands-on, execution-focused role. You will not carry final responsibility for compliance: that stays with our leadership, supported by an established external regulatory consultancy. What you will do is manage and carry out the day-to-day work behind it, from registration dossiers and technical documentation to the quality management system, working closely with our product, supply chain and commercial teams. The registration work is genuinely global. Every market has its own authority, its own dossier requirements and its own timeline, and you will be across all of them.

Your responsibilities

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
• Promote a quality-first mindset across the company

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

Who we’re looking for

You are accurate, structured and organised, and you enjoy turning regulatory frameworks into work that actually ships. You are comfortable juggling several dossiers and deadlines at once, and you like the pace of a scale-up. You do not need to know every market’s system already; you do need the appetite to learn them.

Must-haves

• Bachelor’s or master’s in sciences, medical technology, pharmacy, or related fields
• 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 skills in English (Dutch is a bonus)
• Accurate, structured and organised, comfortable juggling several dossiers and deadlines at scale-up speed

What we offer

• A salary in line with your 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
• International exposure across six regulatory regions, team events, and real room to grow into a broader QA/RA role

Ready to make an impact?

If you would like to take our products to market around the world, send your CV and a short motivation to info@theotclab.com.

No recruiters please — we’ve got this.

Country Manager France
(Medical Devices & OTC Consumer Health)

As Country Manager France, you will have full commercial responsibility for TheOTCLab’s business in France. You will build the market from the ground up and turn it into a sustainable, scalable operation. This is a country entrepreneur role, combining market entry, partnerships, brand building and revenue growth. You will report directly to the founder and work closely with Regulatory, Marketing and Supply Chain.

Excellent Marketing Team

Our Marketing Team supports both you and our distributors by offering a range of tools for effectively introducing our products into targeted markets. These tools range from standard point-of-sale materials to high-end TVC commercials and social media campaigns.

Excellent Support Team

Our support team will help you identify relevant leads, ensure that account management tasks are followed up and manage our sales reporting systems.

Excellent Supply Team

Our supply team is lean and mean and ensures fast deliveries to existing and new distributors. Your responsibility is to keep them very busy!

Excellent Financial Insights  

Our finance team utilizes the latest software to provide daily insights into the financial status of our organization and of the specific requirements of our distributors. With this system in place, you will always have access to the right information for each distributor.

Key responsibilities

• Develop and execute the go-to-market strategy for France
• Identify, engage and contract distributors, pharmacy chains, key accounts and medical partners
• Drive sales growth, pricing, margins and P&L responsibility
• Manage partnerships, marketing localization and brand roll-out

Who we are looking for

You have 10+ years of experience in pharma, medical devices or OTC consumer health, strong knowledge of the French healthcare market, and an entrepreneurial mindset with proven commercial leadership.

What we offer

A leadership role in a rapidly growing European health company, a portfolio of clinically supported products, strong performance-based incentives and the opportunity to build France into a core growth market.

Is this something you have always dreamed of doing and does the profile align with your qualifications? Please send us  a 1-minute introduction video explaining your reasons for applying and why you believe this role is the perfect fit for you.

Senior Key Account Manager — Belgium & Luxembourg

Belgium & Luxembourg | Home-based, with regular presence at our Amsterdam HQ | 0.6 – 0.8 FTE | Reporting to the Director Benelux

Build Belgium into one of our strongest European markets

Belgium and Luxembourg are home markets for TheOTCLab and a central pillar of our European growth plan. We already have a foothold, a portfolio pharmacists recognise and a team that moves quickly. What we do not yet have is one person who owns the market end to end. That is the role we are opening, and it comes with real commercial freedom: your own account base, your own go-to-market plan, and a direct line to the people who make the decisions.

Who we are

TheOTCLab is a fast-growing, certified B Corporation based in Amsterdam. We develop, in-license and distribute everyday self-care solutions, from category-leading distributor brands such as Breathe Right, Just for Men and Vagisil to our own Dr. Yglo, FungeX and Kidsner. Most of our own products are MDR certified and we hold both ISO 13485 and MDSAP certifications, so what you sell is backed by evidence and compliance rather than claims.

We’re proud to be:

• A multiple FD Gazellen Award winner, ranked among the fastest-growing companies in the Netherlands
• A 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
• Headquartered in a creative and collaborative office in central Amsterdam
• Active in 40+ countries and growing fast, with both own brands and third-party distribution

The role

As Senior Key Account Manager you carry commercial responsibility for TheOTCLab in Belgium and Luxembourg. You manage and grow the accounts we already serve, open the doors we have not yet opened, and decide where our brands go next in both the Dutchspeaking and French-speaking parts of the market. Pricing, margin and budget sit with you, and you report directly to the Director Benelux. The role runs at 0.6 to 0.8 FTE, and the scope can grow as the market grows.

What you will do

• Build and execute the go-to-market plan for Belgium and Luxembourg
• Manage and grow our existing key accounts, and win new ones across pharmacy chains, wholesalers, retailers and healthcare distributors
• Own sales growth, pricing, margin and budget for the territory
• Land our brands in both Flanders and Wallonia, adapting the approach to each
• Turn category and sell-out data into concrete account plans, together with Marketing
• Represent TheOTCLab in the market and feed what you hear back into our long-term strategy

What you bring

• At least ten years in pharma, OTC consumer health, medical devices, cosmetics or a comparable FMCG environment
• An established network in the Belgian pharmacy, healthcare or consumer goods market that you can put to work from day one
• A track record of opening new accounts and building partnerships from scratch, not only managing inherited ones
• Fluency in French, Dutch and English, written and spoken
• The judgement to set your own priorities and the discipline to report on them
• Residence in Belgium is strongly preferred

The team

behind you You will be the only TheOTCLab colleague based in Belgium, but you will not be working alone. Four teams in Amsterdam exist to make your accounts easier to win and easier to keep.

• Marketing gives you and your accounts the tools to launch and grow, from point-ofsale materials to TV commercials and social campaigns, across a portfolio of categoryleading brands.
• Commercial support helps you identify leads, follows up on account management tasks and runs the sales reporting systems behind your numbers.
• Supply is lean and fast, delivering to existing and new accounts. Your job is to keep them busy.
• Finance provides daily insight into our financial position and into what each of your accounts needs.

What we offer

• Full commercial ownership of one of our most important European markets
• A highly autonomous role with genuine entrepreneurial freedom, at 0.6 to 0.8 FTE and able to grow with the market
• Work from home, with regular time at our Amsterdam headquarters and the team there
• Direct exposure to senior leadership and to the decisions that shape the business
• A portfolio of clinically supported certified products you can stand behind
• Compensation in line with your experience, with a performance component tied to what you build

Ready to build Belgium with us?

Send your CV and a short motivation to info@theotclab.com. We also like a one-minute video telling us why this market and this role are the right fit for you. We read every application ourselves and come back to you quickly.

No recruiters please — we’ve got this.