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AGA Medical Corporation is dedicated to the development, design, manufacture, and marketing of nitinol-based occlusion devices and accessories for the minimally invasive treatment of cardiovascular defects and peripheral vascular disease.
Our Mission
AGA Medical Corporation is dedicated to the development, design, manufacture, and marketing of nitinol-based occlusion devices and accessories for the minimally invasive treatment of cardiovascular defects and peripheral vascular disease.
History and Future
AGA Medical Corporation is a privately-held medical technology company headquartered in Plymouth, Minnesota.
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| Senior Regulatory Affairs Specialist |
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AGA Medical Corporation, a medical technology company, is dedicated to the development, design, manufacture, and marketing of nitinol-based occlusion devices and accessories for the minimally invasive treatment of cardiovascular defects and peripheral vascular disease.
Summary: Compile, update and maintain Regulatory Affairs submissions in accordance with current country-specific regulations.
Duties and Responsibilities:
Follow department Standard Operating Procedures.
Develop regulatory strategies for new devices as well as for manufacturing and design changes for existing devices for compliance to country-specific regulations.
Review device labeling and advertising materials for compliance to country-specific regulations.
Manage Product Release Authorizations and supporting documentation in required format for assigned countries.
Assemble and maintain regulatory submissions files.
Maintain knowledge of regulations and keep abreast of emerging regulatory changes for assigned countries.
Participate and/or lead process improvement initiatives to streamline regulatory submission preparation processes for assigned markets.
Participate in initiatives to identify regulatory requirements and develop submission processes for new AGA markets.
Other duties as requested.
Physical Requirements:
Sitting for long periods of time.
Frequent keyboard and computer monitor use.
Education, Experience, Personal and Technical Skills:
Bachelor�s degree required; advanced degree preferred.
Excellent organizational, interpersonal and communication (verbal and written) skills.
Computer proficiency in word processing programs.
Minimum 5 years experience in regulatory affairs, preferably with Class III devices.
OUS regulatory submission experience preferred.
Thorough knowledge of Quality System ISO 13485 and Medical Devices Directive.
Ability to interact with a range of personalities and many levels of the organization.
Ability to work independently and take direction from others.
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