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This position serves as the Program Specialist representing the highest level of expertise involving the production and control of all devices and device products (electrical, mechanical, in-vitro diagnostics and computer controlled) to determine compliance with FDA laws and regulations.
WHO MAY APPLY: This vacancy is open nationwide to current permanent (career/career-conditional appointments) employees of the Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) only. Current FDA employees serving under a Schedule A appointment are eligible for consideration. Title 42 employees not eligible for reinstatement will not be considered.
YOU MUST SUBMIT YOUR SF-50.
FDA ORA Commissioned Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.
LOCATION: This position is located in the Food and Drug Administration, Office of Regulatory Affairs, Northeast Region, New York District. The position may be filled in any of the locations listed below. Location and salary will be determined upon selection.
Central Islip, NY
White Plains, NY
New Windsor, NY
TYPE OF POSITION:
This position is being filled on a full-time, permanent basis.PROMOTION POTENTIAL:
GS-13 is the full performance level.
Salary range listed includes locality pay.
If selected for this position, you will:
· Plan, conduct and direct highly technical, complex and multi-faceted inspections and in-depth investigations in the area of medical devices and diagnostic programs.
· Make recommendations to regional and district management officials as to whether or not a firm/individual involved in the production, control and testing of medical devices and diagnostic products is in compliance with Current Good Manufacturing Practices (CGMP) issues.
· Review reports of inspections and investigations for violations within the area of expertise including emergency situations, uncooperative industry officials, ambiguous or dubious evidence and lack of precedents and guidelines.
· Advise on new advances in technology related to medical device products, new programs, laws and regulations, significant court decisions, and any new trends or scientific findings involving medical device products.
· Serve on task forces and study groups charged with considering problems or directions in the area of medical devices.
· Serve as an expert witness in area of expertise in court cases dealing with regulated products.