Regulatory Specialist

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
  • 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%)