Summary of Position with General Responsibilities:|
1. Participates in product development/line extension teams as required to ensure that the product is in compliance with all internal and external regulatory requirements. Develops, documents and implements a regulatory submissions plan around product development/line extension goals.
2. Prepares U.S. FDA submissions (e.g., 510(k), IDE, PMA) as required and per applicable SOPs.
3. Prepares and updates European and international technical files/dossiers/registrations as required and per applicable SOPs.
4. Reviews Engineering Change Orders, Design Change Notices and other deviations for compliance with FDA, European and international regulations and standards.
5. Assists Bard Corporate in updating establishment registrations and device listings as required.
6. Ensures adequate documentation of Bard Peripheral Vascular’s compliance to FDA, European and international regulations and standards. Ensures continuous update and maintenance of the Regulatory Affairs files.
7. Develops working relationships with key personnel/representatives of the U.S. FDA Offices of Device Evaluation and Compliance and Bard Peripheral Vascular’s notified body.
Minimum of 3-4 years RA related experience.
Knowledge of U.S. and/or European and international regulations and standards covering medical devices.
Additional Desirable Qualifications Skills and Knowledge:
Excellent communication (both verbal and written) skills.
Sufficient computer skills (Windows environment).
Good problem-solving and analytical skills.
Education and/or Experience:
Bachelor’s degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field
While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
C. R. Bard is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...