Senior Consultant Regulatory / Biocompatibility
United States, Minnesota, MinneapolisMedical Devices
What you'll do
Currently, Qserve has an exciting opportunity to join our team as a Senior Consultant medical device biocompatibility expert (ISO 10993 series). As a senior consultant, you will be a part of an interdisciplinary group of consultants, leveraging your experience in medical device product development. With your knowledge in biocompatibility and pre-clinical testing, you will be responsible for helping Qserve clients facilitate their business goals by (hands-on) help, assuring regulatory compliance for a wide range of medical devices, many of which are novel applications.
What you’ll bring to the team
The candidate we are looking for is a highly motivated and passionate Senior biocompatibility expert, preferably you are a qualified toxicologist. You have experience in performing biological evaluations of medical devices and toxicological assessments. With your understanding of biocompatibility test protocols, you advise our clients on Biocompatibility test plans and write Biocompatibility evaluation plans and reports. You like writing or reviewing technical documentation and performing compliance assessments of technical documentation against European MDR 2017/745 or FDA requirements.
- 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;
- Direct experience with writing technical documentation and regulatory documents;
- Communicative and service-oriented;
- Fluent in English;
- Working permit and driver's license.
Getting excited about a career in the dynamic and innovating world of medical devices? Then please submit your resume and motivation!
* This function will be executed remotely most of the time. We are open to candidates from all over the US.
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.
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.
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.
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!