Senior Consultant Medical Devices Quality / Regulatory
United States, Minnesota, MinneapolisMedical Devices
What you'll do
Currently, Qserve has an exciting opportunity to join our team as a Senior Consultant Quality / Regulatory. As a Qserve consultant, you serve a wide variety of clients in the medical device industry. With your Quality and regulatory knowledge, 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. In this role you will create, review or compile technical and QMS documentation. Preferably you have auditor qualifications and have performed internal or supplier audits on a regular basis in previous jobs. You thrive on variety and can manage multiple projects.
What you’ll bring to the team
The candidate we are looking for is a highly motivated and passionate senior professional, who is familiar with all aspects of regulatory approval of medical devices in Europa and US and can guide our clients to successful global compliance. You enjoy training and coaching and are able to effectively communicate regulatory and quality related subjects to our clients. We are a service-oriented organization so you must thrive on helping others.
- You have a technical or scientific degree (BSc, MSc or PhD) preferably in physics, mechanical engineering, chemistry, (medical) biology, biomedical technology or similar;
- At least 7 years of working experience in the medical devices industry in Europe or US through positions in industry, consultancy, Notified Body or FDA, in either quality or regulatory (e.g. Manager Quality Assurance or Manager Quality and Regulatory);
- Knowledge of US and EU Medical Device Regulations;
- Direct experience with writing technical documentation and regulatory documents for submissions;
- Experience with Medical device Quality management systems 21CFR820/ ISO 13485;
- Preferably you have auditor qualifications (ISO13485, MDSAP, 21CFR820);
- 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!