Principal Regulatory Affairs Specialist

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 Principal Regulatory Affairs Specialist, you will develop and execute strategies for worldwide governmental approval to introduce new products to market, provide advice on regulatory requirements, prepare regulatory submissions and negotiate approval with the governing body, and support post-market regulatory activities.
REQUIREMENTS
Bachelors degree in Engineering or Sciences; advanced degree preferred.
10 years of direct regulatory affairs experience, preferably in Class III medical devices.
Proven expertise in all aspects of Regulatory Affairs including strategy planning, clinical study design/implementation, submission preparation, all aspects of FDA medical device law/regulations, worldwide regulatory requirements/procedures, project management, and agency negotiations.
Excellent organizational, interpersonal and communication (both written and oral) skills.
Ability to coordinate and manage the completion of multiple projects simultaneously.
Computer proficiency in MS Word, Excel, Project Access, Visio and Outlook.
Ability to constructively interact with a range of personalities and many levels of the organization.
Willingness to travel up to 40%.


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