City      Waltham
State     MA
Job Title     Manager, Regulatory Affairs
Description     Responsible for worldwide product approval submission activities. Plan and implement policies, procedures, practices, and strategies for the Regulatory Affairs. Collaborate with R&D, Clinical, and Quality functions to execute regulatory strategy from product inception to product launch.

Principal Duties and Responsibilities include the following:
Develop, document, and implement regulatory strategy for new technologies and product modifications.

Prepare IDE, 510(k), PMA, CE Mark, and other related regulatory filings. Ensure the timely and accurate filing of regulatory documentation.

Interface with FDA, TUV, and other regulatory agencies regarding regulatory submission strategy and approval reviews.

Collaborate with Clinical to develop clinical trial plans and reports.

Collaborate with R&D to determine and execute pre-clinical test plans in support of regulatory submissions.

Establish and maintain a professional and credible image with FDA, TUV, and other regulatory agencies.

Provide regulatory affairs support to the document control/change request system.

Maintain superior knowledge of competitive technologies in addition to medical and technical developments related to the Company’s products.


Supervisory Responsibilities:
None
Requirements     Education:
Bachelor’s degree in a scientific/technical field; advanced degree preferred.

Experience:
5 years minimum experience in the medical device industry.
4-7 years experience in regulatory is required.
Class III experience is essential.
Demonstrated experience in preparing IDE and 510(k) submissions for FDA; PMA submission experience desired.
Demonstrated experience with submissions to the European Union.
Experience with quality is preferred.

Knowledge/Skill:
Strong interpersonal skills
Excellent writing skills
Excellent oral presentation skills
Strong analytical skills
Function     Quality