Sr. Regulatory Affairs Manager

Helping Hearts Heal Themselves


AGA Medical Corporation specializes in the development and manufacturing of innovative medical devices for use in cardiovascular applications. AGA's patented AMPLATZER family of occlusion devices offers new and enhanced solutions for transcatheter treatment of complex congenital heart defects. We are a fast-growing, innovative company, looking for creative professionals to join our team.


As a Sr. Regulatory Affairs Manager, you will provide medical and scientific expertise in the areas of general and interventional cardiology relating to AGA Medical products. The role functions as an internal consultant for clinical trial design, conduct and analysis, R&D, regulatory and marketing activates. The position will directly interact with clinical and academic investigators involved in clinical trials and will drive the scientific communication.
REQUIREMENTS
Medical degree: Board certification in Cardiology/Interventional Cardiology.
Five years clinical/patient care experience.
Three years experience designing device clinical trails.
Experience writing, publishing and presenting scientific reports to the medical community and medical device stakeholders.
Demonstrated experience interfacing with FDA on the medical elements of clinical trail design.
Proven track record of working independently, while achieving functional objectives.
Proven ability to effectively operate and communicate in a matrix environment and work effectively with management, scientific stakeholders, and across business and organizational boundaries.
Self-confident, analytical and strategic thinker with the highest personal integrity.
Pro-active person with the ability to manage a critical path toward product commercialization.
The capability to envision the application of new technologies in novel ways to solve complex medical device needs.


For a more detailed job description, please visit our website at www.amplatzer.com.


We offer an excellent compensation and benefits package including medical, dental, life insurance, disability, 401(k), and much more.


An Equal Opportunity / Affirmative Action Employer


Please, No Agencies