Consultant Medical Devices Regulatory Affairs The Netherlands

What you'll do

Currently, Qserve has an exciting opportunity to join our team as a Consultant Regulatory. As a Qserve consultant, you serve a wide variety of clients in the medical device industry. With your regulatory knowledge of medical devices, you will be responsible for helping Qserve clients facilitate their business goals by (hands-on) help, assuring regulatory compliance, and market access for a wide range of medical devices. You will be part of a team of medical device experts, working from across the world, dedicated to supporting our clients.

What you’ll bring to the team

The candidate we are looking for is a highly motivated and passionate Regulatory professional, who has experience in writing and reviewing technical documentation of medical devices. With your understanding of design and development processes (specifications, verification, and validation) and risk analysis you are able to engage a large variety of medical device technologies and guide clients to successful global compliance. In this role, you thrive on variety and be able to manage multiple projects. You enjoy teaching and coaching and are able to effectively communicate regulatory subjects to both technical and non-technical people. We are a service-oriented organization so you must thrive on helping others. You like to write technical documentation and regulatory documents.

Your profile:

• Technical or scientific degree (BSc, MSc, or Ph.D.) in physics, mechanical engineering, chemistry, (medical) biology, biomedical technology, or similar;

• At least 4 years of working experience in the field of medical devices (EU-MDD and EU-MDR) through positions in industry, consultancy, or Notified Body, in either quality, regulatory or clinical roles (e.g. Regulatory Affairs specialist or & Quality and Regulatory manager);

• Knowledge of Medical Device Regulations (EU MDR, US regulations etc.);

• Familiar with risk management of medical devices

• Direct experience with writing technical documentation and regulatory documents;

• Experience with Medical device Quality management systems / ISO 13485;

• Pragmatic, enjoying a mix of activities in regulatory affairs or quality assurance;

• Communicative and service-oriented;

• Strong organizational skills, detail-oriented to deal with various projects at the same time;

• Fluent in English and Dutch;

• Driver's license; 

Interested?

Getting excited about a career in the dynamic and innovating world of medical devices? Then please submit your resume and motivation!