Skip to content

IVD Regulatory Affairs Consultant

Netherlands, Gelderland, ArnhemIn-Vitro Diagnostics

Job description

What you'll do

As a Regulatory Affairs Consultant at our company, you provide specialist consulting services directly to customers. This could involve supporting customers' transition from the IVDD to the IVDR or gaining CE marking, FDA clearance or approval, or approvals in China for the first time.


As a consultant, no two days or customers are the same. You may be required to build a technical file to support CE marking or 510(k) submission or similar global approvals; however, it could also include strategy planning, in-depth reviews of performance evaluation or risk management data, creating and reviewing quality management system policies and procedures, performing gap analyses, internal or supplier audits to support and improve customers quality systems or perhaps delivering customer training.


You will be part of a team, no one is an expert on everything, so we support each other to play to our strengths so that we provide the best service to customers. This position is a great opportunity to apply your expertise and continue to build your experience. We know how important it is for our customers that we maintain our experience to be state of the art and we, therefore, hold monthly Qserve training days to ensure we provide consistent advice to customers as well as to continue to learn from each other.


Job requirements

What you’ll bring to the team

  • You have a technical or scientific degree (BSc, MSc, or Ph.D.) in (bio)chemistry, toxicology, (medical) biology, biomedical technology, or similar. Preferably a qualified toxicologist Familiar with ISO 10993 series;
  • At least 7 years of working experience in the field of medical devices (EU-MDD and EU-MDR) through positions in industry, consultancy or Notified Body, FDA in regulatory roles (e.g. Manager Regulatory Affairs);
  • Knowledge of Medical Device Regulations (EU MDR, FDA, PAL, TGA, etc.);
  • Familiar with medical device quality assurance;
  • Familiar with writing technical documentation and regulatory documents;
  • Pragmatic, enjoying a mix of activities in regulatory affairs or quality assurance;
  • Communicative and service-oriented, supporting a wide variety of clients from small start-ups to large multinationals, able to adapt to different company cultures and situations;
  • Strong organizational skills, detail-oriented to deal with various projects at the same time;
  • Competent in communication, analysis, and advice and taking ownership of your work and personal development;
  • Fluent in English.


Interested?

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

or

How we hire

Everything you need to know about your application process at Qserve Group

Getting to know you

In the first call, let our recruiter learn about you and your story to check a potential fit for Qserve. This is also a chance for you to ask first questions about the role and company.

Interview

In this meeting, your future manager takes a deeper dive into your experience and what you could bring to the team. Expect questions on how knowledgeable you are in your area of expertise.

Final chat

You made it to the very last stage! Here we have a final call to ask some additional questions. This meeting will be between you, your future manager and a team member.

Mutual interest

Is there a match? Then we will gladly make you an offer consisting of a suitable salary and our employment conditions. Do you accept our offer? Your adventure at Qserve Group will start!