Regulatory Specialist
Apply NowCompany: Route 92 Medical
Location: San Mateo, CA 94403
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:
REQUIRED EDUCATION:
EXPERIENCE:
OTHER:
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
- Summary of Safety & Clinical Performance
- Instructions for Use
- Product labeling
- Post-Market Surveillance Reports
- Communicate with key regulatory suppliers such as notified body, in-country representatives, importers, distributors, etc.
- Identify new or revised regulatory requirements, complete state-of-the-art reviews (gap assessments). Update the quality system where required.
- Identify opportunities for improvement of regulatory processes and implement where applicable.
- Identify, Investigate, and implement corrective and preventative actions related to regulatory processes.
- Act as lead or supporting auditor for Internal or Supplier Audits.
- Support relevant areas in external audits.
- Other regulatory tasks as request by management.
REQUIRED EDUCATION:
- B.S. in regulatory affairs or relevant scientific discipline.
EXPERIENCE:
- Knowledge of 13485:2016, EU MDR, MDSAP (and relevant international regulations). Certification is a plus.
- At least 4 - 8 years of experience as a Regulatory Specialist.
- At least 5 years of experience in a medical device regulated environment.
OTHER:
- Travel (5%)