Headquartered in Brisbane, Calif., CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers products, testing services and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients.
We are now looking for a Head of Regulatory Affairs to join our site in Stockholm!
The CareDx Stockholm site develops and manufactures HLA typing products on
two different platforms: QTYPE® is our qPCR-based HLA typing system, and Olerup
SSP® is our PCR-based HLA typing system. The products are developed for the
global market and HLA typing is used in transplantation as part of matching
between recipients and donors. HLA typing is a standardized test for bone
marrow and organ transplants; the better the match, the lower the complication
risk after transplantation. You will report to CareDx Pty, Fremantle,
Australia. The position is located at the CareDx office in Stockholm, Sweden.
- Primarily act as the main point of contact with Regulatory Authorities and internal/ external stakeholders such as regulatory partners, translators, Quality, Supply Chain, Commercial and work cross-functionally.
- Responsibility for product registrations. Ensure correctness regarding submission or any other local requirements.
- Monitoring of new regulatory and legal requirements to ensure compliance for commercially available products and products under development.
- Ensure IVDD, IVDR and EN ISO 13485:2016 regulatory compliance.
- Regulatory functional budget responsibility
- As part of the wider Global CareDx Regulatory Affairs team, having overall responsibility for post-approval/life-cycle Regulatory activities
- Member of the Site Lead Team
- At least 5 years’ of demonstrated experience and an excellent track record in management level Regulatory Affairs position(s) within the Medical Devices/IVD industry.
- The position puts high demands on being able to act independently but also effectively collaborating internally, as well as externally. Effective interpersonal skills are a requirement.
- The role requires an organized, structured, accurate, independent and pro-active way of working. You must have strong analytical and project management skills combined with a communicative ability and being detail oriented.
- Excellent communication skills in both oral and written English
- Support in Quality Assurance activities as applicable
We would like your application to include a CV and a cover letter in English. Please send your documents to email@example.com asap, or contact Daniel for questions under 0733-87 27 24!