Regulatory Affairs Principal Specialist
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.
BIOTRONIK is looking to add a Regulatory Affairs Principal Specialist to our new Neuromodulation Segment . The Regulatory Affairs Principal Specialist performs advanced regulatory work requiring recognized expertise in aspects of premarket submission and related postmarket FDA regulations and guidance. This individual is responsible for planning, preparation and management of FDA submissions for approvals of medical devices, including Class III active and passive implantable devices. This individual plans, directs and completes FDA submission packages incl. original PMA’s , as well as related internal documentation. This individual guides and directs Regulatory activities for existing products with respect to design, manufacturing and labeling changes, as well as review and approval of promotional material. The Regulatory Affairs Principal Specialist monitors regulatory intelligence and provides regulatory guidance throughout the organization, throughout the product lifecycle.
Required Education and Experience:
Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.
Location: Lake Oswego, OR | Working hours: Full-time | Type of contract: Undefined
Apply now under: www.biotronik.com/careers
Job ID: 37182 | Contact: Amanda Willott
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.
Weitere Jobangebote von BIOTRONIK