A major medical device manufacturer is seeking a Regulatory Affairs Specialist to provide guidance in the development, preparation, retrieval, and maintenance of regulatory submissions, e.g. 510(k)s, product introduction into the U.S. Pricebook, and the review of promotional material and device labeling for regulatory compliance.  This position will work closely with management and the other RA/CA Specialists to help align the department objectives with the overall department activities.  This position interfaces with multiple functional areas, geographies and divisions.

Responsibilities:

-           Assist with the coordination of the RA/CA department duties as assigned; such as, developing regulatory strategies; budget review; department learning plan; coordinating the department input for group collaborations when needed (department meetings/presentations, process improvements, group expertise, etc.); other duties as assigned

-           Prepare, review and file appropriate FDA per market submission to ensure devices are commercially available in the U.S.

-           Development and documentation decisions not to seek FDA clearance/approval

-           Review promotional material and labeling for regulatory compliance.

-           If necessary, participate in the development of IDEs and associated clinical studies

-           Control the introduction of product to the United States market through management of the Product Introduction Form (PIF) Process

-           Provide regulatory training to divisional CSG staff and German based staff to ensure an appropriate understanding of applicable regulations and procedures

-           Assists in the development and enhancement of procedures to optimize efficiency and compliance

-           Assists the CSG Regulatory, Quality and Clinical Affairs Department in ensuring its responsibility for the QSR compliance of the CSG organization

-           Assists the development of the Regulatory Affairs budget and help ensure operations are within that budget

Requirements:

Education:  Bachelor’s Degree (BS or BA), preferably in a technical discipline, life sciences field or related discipline. 

Knowledge:  Comprehensive knowledge of U.S. FDA regulations relating to (510(k)s, PMAs and the review of promotional and labeling materials.  Demonstrated ability to develop an advanced knowledge of a company’s systems and products.

Experience