DO YOU SHARE OUR PASSION FOR HELPING MEDICAL DEVICE MANUFACTURERS TO TAKE GROUNDBREAKING INNOVATIONS TO THE MARKET?
Clarvin is looking for experts within Medical Device Regulatory Affairs and Quality Assurance to join our team. We are a rapidly expanding Swedish-based consultancy firm specializing in Regulatory Affairs and Quality Assurance for medical devices. We provide our clients with in-depth regulatory and quality expertise. Our consultancy team is leading the way in addressing the new requirements for medical devices under the new EU medical device regulations. We are also working with medical device clearances in the US and registrations in the rest of the world.
The demand for our work is high and we are focusing efforts on expanding our team to fulfil the needs of our international client base. Candidates should be interested in working with small to medium size companies in a rapidly growing team. We seek eager and quick learners, excellent writers, and those flexible in their approach to working in a collaborative team environment with colleagues and clients all over the world. Candidates can be based in the EU or US and work with clients on distance.
- Experience in working with Medical Device Regulatory Affairs, Quality Assurance and/or Biocompatibility
- Experience in establishing Technical Files (or Design Dossiers) for EU purpose
- Experience in establishing 510(k) – preferable
- Experience in international medical device registrations – preferable
- Degree in a relevant scientific discipline
- Excellent grammar and communication skills, written and oral
- Attention to detail and scientific accuracy
- Ability to interpret EU and US Medical Device Regulatory requirements
- Ability to understand and summarize product data and present other complex information in product file(s)
- Service minded and very good communication skills (written and oral)
- Experience working effectively with cross-functional teams
- Proficiency in MS Office
Please send your CV and Cover Letter to firstname.lastname@example.org