Sr. Regulatory Affairs

Sr. Regulatory Affairs
Company:

Zachary Piper Solutions, Llc


Sr. Regulatory Affairs

Details of the offer

Piper Companies
is currently looking for an experienced
Sr.

Regulatory Affairs Specialist
in
Somerville, NJ
to work for an innovative and growing medical device manufacturer. The Regulatory Affairs Specialist will play in pivotal role in the development of new medical implants and the revision of legacy products
Responsibilities for the Sr. Regulatory Affairs Specialist include:
Cooperate with the product development and management teams to prepare/ review 510k submissions
Work with personnel in various functional areas to obtain timely submissions to FDA
Prepare, support, and maintain technical rules in accordance with MDR.
Review and file Note-to-File documentation for minor changes to 510(k) cleared products or systems.
Assist in the preparation of FDA reports and or other documentation.
Ensure conformance to 21 CFR regulations, 1S013485,1S014971, & EU MDR.
Qualifications for the Sr. Regulatory Affairs Specialist include:
BS or higher degree in Regulatory Affairs
2+ years of experience in the medical device experience
Hands on experience with 510k submissions
Compensation for the Sr. Regulatory Affairs Specialist include:
Salary Range is dependent upon experience
Comprehensive benefits package


Source: Dice


Area:

Requirements

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