What are the responsibilities and job description for the Regulatory Specialist position at Route 92 Medical Inc?
Job Description
Job Description
Location : Either San Mateo, California or West Jordan, Utah
PURPOSE OF JOB :
This position will support Route 92 Medical's efforts to sustain a best practice Quality System by ensuring compliance to regulatory requirements (13485 : 2016, MDSAP, EU MDR 2017 / 745) as well as ensuring products meet all applicable internal and external requirements and specifications.
MAJOR DUTIES AND RESPONSIBILITIES :
- Reportability Assessment of product field complaints.
- Change Assessment of relevant Design, Manufacturing, or Quality System changes.
- Lead or support Facility Registration activities as required by responsible authorities in relevant regulatory regions.
- Lead or support Device Market Authorization activities as required by responsible authorities in relevant regulatory regions. (Primarily OUS)
- Completes Distribution Authorization documentation to allow product distribution through the Quality Management System / ERP System.
- Update or maintain relevant regulatory related documentation including but not limited to :
General Safety & Performance Requirements checklists
REQUIRED EDUCATION :
EXPERIENCE :
