Compliance Expert - Product Safety

As a Compliance Expert, you ensure that products such as medical devices are safe, reliable, and fully compliant with European and international regulations. 

You are the key link between technology, quality, and legislation: you verify whether manufacturers and their medical devices and/or other technical products comply with all applicable laws and regulations when entering the European, British, and/or Swiss markets. 

• For non-EU manufacturers, you act as the official European Authorised Representative (EAR/EU Rep). 

• For European manufacturers, you arrange market access to the United Kingdom (UK Authorised Representative / UK Responsible Person) and/or Switzerland (CH-REP). 

In short, you make it possible for products—including medical devices—to reach customers worldwide in a responsible manner. 

Your responsibilities 

• Supporting manufacturers entering the European, British, and/or Swiss market 

• Verifying compliance with relevant (medical) legislation and regulations related to product conformity and product safety 

• Reviewing and managing technical documentation 

• Acting as Authorised Representative (EAR) for non-EU manufacturers, including product registration and communication with competent authorities 

What do you bring? 

• A Bachelor’s or Master’s degree in a relevant field, such as: Biomedical Engineering, Technical Medicine, Quality & Safety in Healthcare, Regulatory Affairs, or Law/Business Administration with an affinity for medical devices or product safety 

• Knowledge of relevant product safety or medical device regulations such as MDR/IVDR 

• Understanding of quality management systems such as ISO 13485, ISO 27001, or ISO 9001 

• Experience with CE marking, technical documentation, post-market surveillance, and vigilance 

• Strong analytical and organizational skills: you can translate regulations into practical processes and guide teams in their implementation 

• Excellent communication skills in Dutch and English; proficiency in German and/or French is a plus 

What do we offer you? 

We care about doing a good job and about each other. Every two weeks we get together for brainstorm and inspirational sessions. At the end of every quarter, we celebrate our successes and strengthen our team spirit.  

• A salary between €3,500 – €5,000 gross per month based on full-time employment 

• Lease car or mobility allowance 

• Training and certification opportunities 

• Pension scheme, smartphone, and laptop 

• 28 vacation days 

• Discount on collective health insurance (VGZ) 

• Vitality budget 

• Lease-a-bike scheme 

• Work-from-home allowance 

• Disability insurance 

Who are we? 

Kader Group helps organizations realize their ambitions by translating legislation and regulations into practical solutions. With over 400 colleagues, we work in the fields of quality, safety, health, cybersecurity, and sustainability through consultancy, interim services, digital solutions, and training programs. We offer plenty of room for growth, the opportunity to explore new paths, and the freedom to shape your own direction. Our mission is to create a safe and sustainable living environment for future generations; working in a pragmatic, innovative, personal, and professional manner. 

Our close-knit team consists of young, enthusiastic professionals with a strong drive to deliver high-quality work. We are proud of our flat organizational structure. Lines are short and informal. We also provide you with the space to choose your own path and development. 

You will have the opportunity to grow both personally and professionally. You will work in a team with a personal approach, and we offer you freedom, trust, and flexibility. You will have the space to make a real impact within the organization and to position yourself as an expert—both within our team and in the market. 

Do you want to leverage your expertise to ensure that products comply with regulations worldwide and reach the market safely? Apply now and strengthen our team as a Compliance Expert – Product Safety!

Submit your application via j.v.spiekerman@kader.nl or contact Josephine Spiekerman (Corporate Recruiter) at +31 6 86845544.
Prefer to have an initial chat first? That’s perfectly fine. Together, we can explore whether this role is the right fit for you – and whether you are the right fit for us.