Manage, plan, and coordinate the work of Regulatory Affairs department.

Implement company and departmental goals, objectives, and enforce requirements of quality work.

Participate in product development/SE teams as required to ensure that the product is in compliance with all internal and external regulatory requirements. Develop, document, and implement a regulatory submission plan around product development goals.

Prepare U.S. FDA 5l0(k), IDE, PMA, submissions as required. Ensure that all submissions are accurate and completed in a timely manner, and that all arguments presented in the submission are appropriate, defendable, scientifically based and meet Bard Corporate standards.

Prepare and update Europeans and international product dossiers/registrations as required. Ensure that all submissions are accurate and completed in a timely manner, and that all arguments presented in the submission are appropriate, defendable, scientifically based and meet Bard Corporate standards.

Review all clinical and marketing study protocols for compliance with FDA, European, and international regulations and standards.

Review all Engineering Change Orders for compliance with FDA, European, and international regulations and standards.

Coordinate the review of FDA submissions and labeling by BARD Corporate Regulatory and Medical Affairs, and Legal Department.

Assist Bard Corporate in updating establishment registrations and device listings as required.

Develop Standard Operating Procedures (SOPs) implementing FDA, European, and international regulations and standards as appropriate.

Develop working relationships with key personnel/representatives of the U.S. FDA Offices of Device Evaluation and Compliance, and notified body.

Candidate Requirements:

1.)We seek a Regulatory Affairs professional with a proven track record of successful submissions. Minimum of six years of Regulatory Affairs experience, plus two years supervisory experience required.

2.)We seek a professional with a life sciences degree in a technical area such as biology, chemistry, physiology, engineering, medical or law.

3.)Candidates must have comprehensive knowledge of US, European, and international regulations and standards covering medical devices.

4.)Clinical Development experience as well as Infectious Disease / anti-microbial experience is a plus.

5.)Regulatory Affairs Certification is desired.

6.)For the best fit, you should be a hands-on, results-oriented professional who is a strong team player, an excellent communicator, and capable of working independently.

Compensation:

A compensation package will be designed to attract outstanding talent and will include a base salary, performance bonus and excellent benefits.