Senior Regulatory Affairs Specialist

SENIOR REGULATORY AFFAIRS SPECIALIST

Clearwater, FL

Our Client has engaged us in a search for a Sr. Regulatory Affairs Specialist to work out of their facility in the Clearwater, FL area. 

Premier Recruitment Group works with leading companies in identifying top tier talent for significant career opportunities.  We are seeking an experienced individual that brings Regulatory Affairs experience from the medical device or medical imaging industries.

Position Description:

The Sr. Regulatory Affairs Specialist will be responsible for designing & implementing global regulatory compliance strategies; to enhance efficiency and productivity in completing tasks and managing projects; prepare and maintain required documentation to assure global compliance.  Execute and manage product registrations for USFDA submission 510(k), CE-mark certificate and other international registrations, which includes creating and maintaining Technical Files and supportive documents. Provide timely review and approval of product labeling for regulatory compliance.

Qualifications:

Candidates should possess a Bachelors Degree plus a minimum of five (5) years of related experience in Regulatory Affairs including hands on submission experience. 

In return, you will enjoy a competitive compensation package up to along with full benefits and possible incentives.  This outstanding personal and professional opportunity provides for more than usual autonomy within a state of the art facility with industry-wide recognition.

For immediate consideration, please send resume to:

Courtney Bricks

Premier Recruitment Group

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