Regulatory Project Manager for Transcatheter Aortic Valves (f/m)
As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.
The regulatory affairs department is responsible for worldwide registration of the newly developed products and the existing portfolio. With newly developed class III innovative products the regulatory affairs department offers a great opportunity to work on challenging regulatory submissions.
- Provide regulatory input and ensure regulatory compliance for the development of Transcatheter Aortic Valves and other devices to treat structural heart diseases.
- Clarification of the regulatory requirements and successful registration of the above mentioned devices in Europe, USA and other highly regulated countries such as Canada, Australia and Japan.
- Elaborate the regulatory strategy, identify the applicable standards and guidelines required in the above mentioned countries and ensure their application during product development, verification and validation.
- Regulatory project management including planning and coordination of all submission related activities, organizing and leading presubmission meetings with notified bodies and national competent authorities.
- Maintain regulatory documentation up to date for worldwide regulatory purposes.
- Establish and update internal procedures to enable up to date and consistent output, as well as efficient work flow within the department and project team.
- University degree or PhD in natural science, medicine or engineering.
- Several years of experience as a regulatory project manager in the registration of Transcatheter Aortic Valves in higly regulated countries, particularly in Europe, USA and Japan.
- Proven track of successful registrations of invasive high risk cardiovascular implants and suceessful interaction with the regulatory authorities in the above mentioned countries.
- Excellent knowledge of the regulations, standards and guidelines applicable to class III medical device in general and Transcatheter Aortic Valves and animal tissues in particular in the above mentioned countries including current developments (e.g. MDR).
- Experience in project management.
- Independent, reliable and communicative personality who is able to deliver high quality work even under pressure and to handle several projects simultaneously.
- Fluency in English.
Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.
Location: Bülach | Working hours: Vollzeit | Type of contract: Unbefristet
Apply now under: www.biotronik.com/careers
Job ID: 22381 | Contact: Bianca Wisner | Tel. 044 864 51 07