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
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:
Ms Katrin Biedermann Wildenbruchstraße 15 D-07745 Jena