Global Head of Regulatory & Quality Affairs at Occlutech
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 and accessories for the transcatheter repair of structural heart defects, including a range of specialized devices for patients with heart failure. 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.
Primary responsibilities include formulating and implementing the Company’s Regulatory Affairs, Quality Management/Control strategies and procedures. This includes leading and directing the Company’s RA/Q staff in Germany, Turkey and Sweden in key areas including (i) the registration Class III medical devices in North America & China, (ii) the creation of a Company-wide QM System compliant with the latest standards and requirements, and (iii) the MDD to MDR/MDSAP transition. The successful candidate will be required to closely work with Clinical and R&D departments at the Company’s sites. The position requires managing and coordinating interactions with European, U.S., Chinese and other international authorities and ministries, as well as the Company’s distributors, contractors, or consultants. Extensive travel will be required.
- Minimum of 10 years of aggregate experience working in Regulatory Affairs Quality Management, in the medical device industry
- A minimum of 6 years of managerial/supervisory experience
- Knowledge of, and substantial experience with regulations and guidelines pertaining to the medical device industry, including but not limited to: ISO 13485:2016, 21 CFR 820, Medical Devices Regulation (MDR), and the Medical Device Single Audit Program (MDSAP)
- Track-record of successful Class III Medical Device registrations (European Economic Area, U.S. FDA, Health Canada, as well as in other markets)
- Excellent leadership, interpersonal and communication skills
- Ability to effectively work in a fast-paced, multicultural environment
- Hands-on working style
- University degree
- Excellent spoken and written English is a must
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Maria Boström (Executive Search) +46(0)40301026 / firstname.lastname@example.org
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