Regulatory Affairs Specialist - Product Registration, Medical Devices (m/f/d)

Regulatory Affairs Specialist

Occlutech is the leader in developing innovative products for the treatment of structural heart disease. The Company manufactures, develops, sells and markets Class III medical devices for the transcatheter repair of structural heart defects, including a range of specialized devices for patients with atrial fibrillation or heart failure, in over 90 markets around the world. Occlutech operates facilities in Germany, Turkey and Sweden. For additional information please visit our website at www.occlutech.com.

Location: Jena
Reports to: Global Head of Regulatory and Quality

Position Description:

Broad Function
As a member of our international RA team located in Jena, Helsingborg and Istanbul, the RA Specialist supports the Regulatory Affairs department in international product registration. Fulfilling these tasks means to be in constant close contact with our Clinical Research and Research and Development departments as well as with Quality Management.

Your work will focus on

  • Submission, surveillance and maintenance of international product registration including the preparation, legalization and shipment of regulatory documents.
  • Co-ordination of additional test procedures and shipment of testing material
  • Communication with suppliers, distributors or sales representatives
  • Maintenance of a data base on international product registrations
  • Reports on status, changes or any news to management

We are looking for a candidate, who has

  • Technical Scientific Degree (minimum bachelor of science)
  • Knowledge in medical device regulations
  • Minimum of 1- 2 years work experience in regulatory affairs departments, preferably
    in the medical device industry
  • Exceptional knowledge of English
  • Very good social and communication skills

If you are

  • a team player who likes challenges
  • a confident user of standard office software
  • excellent in leadership, communication, organization and time management
then we can offer you an interesting job in a team of people who like to work together and always focus on helping our customers to save and improve patient’s lives with innovative and highest quality products.

Are you interested?

We look forward to receiving your application (cover letter, CV, references - all documents in one pdf file), your salary expectation and the earliest possible date for start of work to bewerbung@occlutech.com .

Occlutech GmbH
Winzerlaer Str. 2
D-07745 Jena
bewerbung@occlutech.com
www.occlutech.com

While applying for the job please refer to jobvector

About Occlutech GmbH

Occlutech was founded in Germany in 2003, and has since developed into one of the world´s leading suppliers in the area of structural heart disease with products and projects for; congenital defects, stroke prevention, and heart failure. The company´s products are sold in over 80 countries globally and the total number of implantations is approaching 100.000, setting the highest standards...
More about Occlutech GmbH