Regulatory Affairs Manager

Occlutech is the leader in developing innovative products for the treatment of structural heart disease. The Company 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 50 markets around the world. Occlutech operates facilities in Germany, Turkey and Sweden. For additional information please visit our website at www.occlutech.com.

Position: Regulatory Affairs Manager (m/f) North America

Location: The successful candidate will be based in either Istanbul, Turkey or Jena, Germany

Reports to: Global Head of RA/QA

Primary responsibilities of the successful candidate include managing, implementing, maintaining and improving the Company’s North American Regulatory Affairs procedures and objectives within Occlutech. This will include working together with quality and Regulatory Affairs, Quality Control/Management and R&D staff across the organization. The Manager of North American Regulatory Affairs will also responsible for coordinating interactions with primarily with Health Canada and the U.S. FDA. Moderate travel may be required.

Your work will focus on

  • Coordinate all regulatory affairs related activities pertaining to North American registration projects with affected Site and managements
  • Preparing Regulatory Affairs plans, budgets and timetables
  • Maintaining close and effective working relationships with the Company’s Quality Assurance staff
  • Managing and coordinating North American registrations of Occlutech products in accordance with applicable standards & regulations in order to obtain necessary permits
  • Manage and lead the communication with notified bodies or other relevant agencies during the process of regis-trations
  • Inform notified bodies or other relevant agencies regarding any changes applied to Occlutech products and obtain necessary approvals in a timely manner

We are looking for a candidate, who

  • Minimum of 7 years of aggregate experience working in Regulatory Affairs in the medical device industry
  • Knowledge of, and experience in CE marking processes as they pertain to Class III medical devices
  • Knowledge of, and experience in international regulations and guidelines as they pertain to Class III medical de-vices
  • Excellent interpersonal and communication skills
  • Managerial/supervisory experience a plus
  • University degree
  • Fluent English a must

If you are

  • A team player who likes challenges
  • A confident user of standard office software and familiar with Quality System Stadards (such as ISO13485 and FDA QSRs)
  • Fluent in written and spoken German and English
  • Excellent in leadership, communication, organization and time management
  • Open to occasional international travel

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?

Please send your application (cover letter, CV, references - all documents together in one pdf file), your salary expection and the earliest possible date for start of work to:

Occlutech GmbH
Ms Katrin Biedermann
Wildenbruchstraße 15 
D-07745 Jena 

katrin.biedermann@occlutech.com
Tel: 03641-508323

www.occlutech.com