Head of Regulatory Affairs (global)

  • CareDx
  • Stockholm
  • Publicerad: 22 november, 2019
  • Fulltid

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 yo 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.

Responsibilities:

  • 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

Qualifications:

  • 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

Your Application:  

We would like your application to include a CV and a cover letter in English. Please send your documents to daniel.kremer@moveup.se asap, or contact Daniel for questions under 0733-87 27 24!

 

Share on FacebookTweet about this on TwitterShare on LinkedIn

Ansvarig rekryterare

Daniel Kremer

daniel.kremer@moveup.se
+46 (0)733-87 27 24

moveup-bw@2x

Göteborg: Ullevigatan 19, Tel: 031 - 775 55 90
Stockholm: Saltmätargatan 8, Tel: 08 - 661 73 90
Cookies
Integritetspolicy

barnsupporter-foretag-2019_marke

Share on FacebookTweet about this on TwitterShare on LinkedIn