International Regulatory Project Coordinator

International Regulatory Project Coordinator

Occlutech is the leader in developing innovative products for the treatment of structural heart diseases. The Company develops and markets occlusion-based technology to repair congenital heart defects and para- valvular leaks in over 80 markets around the world. Occlutech operates facilities in Germany, Turkey and Sweden. For additional information please visit our website at www.occlutech.com.

We are now looking for an International Regulatory Project Coordinator to strengthen our growing registration department.

Position description: Primary responsibilities will include assisting the Company’s Global Head of Regulatory Affairs and Quality Management in filing and maintaining international medical device registrations. The position requires interacting with regulatory and clinical affairs, as well as other professionals at Occlutech’s sites (Sweden, Turkey and Germany) and with the Company’s OEM manufacturers, suppliers and distributors worldwide.

Principal responsibilities
  • Submitting, filing, monitoring and maintaining international product registrations
  • Compiling, legalizing and shipping of regulatory and other required legal documents
  • Coordination of additional testing procedures as may be required; including coordination for test material shipping
  • Interacting with third party manufactures, distributors or agents as may be required (e.g. supporting international tenders)
  • Maintaining international product registration data base (timelines, status & costs)
  • Provide timely & regular updates to the Global Head of RA/QM and Senior Management
  • Compiling of data, summaries and reports
  • Status of ongoing registrations
  • Changes of timelines, rules and regulations
  • Any new issues that may arise
  • General administrative tasks such as copying, filing, etc.
Requirements:
  • Solid experience of administration and know-how in regards to finding information about current laws and regulations in different countries
  • Experience of Regulatory Affairs is an advantage
  • Ability to work well unsupervised and in a team environment
  • Independency, detail orientation as well as creativity
  • Capability to manage multiple projects at the same time
  • Ability to work in a diverse, multinational environment
  • Excellent written and verbal communication skills both in Swedish and English. Additional language skills are an advantage
Are you interested?

We handle screening and selection ongoing and therefore encourage you to apply as soon as possible, but no later than July 22nd 2018. Apply by clicking on "Sök tjänst".
Please upload your CV and cover letter in English. All enquiries are treated confidentially.
We don´t accept applications via email.

For further information regarding the role please contact Johanna Isberg, tel +46 705 843383 or email johanna.isberg@roirekrytering.se.
Mer info
Område Helsingborg
Yrkesroll Administration, Koordinator
Typ av anställning Heltid, Tillsvidareanställd
Sista ansökningsdag 23 juli (33 dagar kvar)