POSITION: Senior MDR Specialist
FULL-TIME/PART-TIME: Full Time
LOCATION: Remote
GENERAL SUMMARYThe Senior MDR Specialist is responsible for overseeing the end-to-end medical device complaint handling process, ensuring compliance with global post-market surveillance and vigilance requirements. This role manages a team responsible for complaint intake, investigation oversight, eMDR submissions to the U.S. FDA and Medical Device Problem Reporting to Health Canada. The Senior MDR Specialist partners closely with Quality, Regulatory Affairs, Service/Technical Support, Engineering, and Original Equipment Manufacturers (OEMs)/Suppliers to ensure timely identification, assessment, investigation, and escalation of product quality and safety issues while driving continuous improvement initiatives.
QUALIFICATIONSPreferred Education- Bachelor's degree in Life Sciences, Biomedical Engineering, Nursing, Quality, Regulatory Affairs, or a related scientific field.
Preferred Experience- 5+ years of experience in medical device complaint handling, vigilance, post-market surveillance, or quality systems.
- 2+ years of leadership or supervisory experience preferred.
- Demonstrated experience with FDA reporting and Health Canada Medical Device Problem Reporting.
- Experience working within an ISO 13485 and FDA-regulated environment.
DUTIES AND ESSENTIAL FUNCTIONSEach Employee consistently demonstrates the following essential functions:
Complaint Handling & Vigilance- Supervise daily operations of the MDR complaint handling team.
- Ensure complaint records are accurately documented, investigated, and closed within established timelines.
- Conduct Quality Check (QC) Reviews for complaint record completeness, quality, and regulatory compliance.
Regulatory Reporting- Conduct the review and submission of Medical Device Reports (MDRs).
- Ensure timely determination of reportability in accordance with 21 CFR Part 803.
- Maintain reporting metrics and ensure compliance with global vigilance requirements.
CAPA & Quality Systems- Support CAPAs arising from complaint investigations, adverse events, audits, inspections, and trend analyses.
- Support root cause investigations utilizing tools such as 5 Whys, Fishbone Diagrams, and Failure Analysis.
- Support internal and external audits, including FDA, Notified Body, and ISO 13485 audits.
Leadership & Team Management- Coach and mentor MDR complaint handling personnel.
- Drive a culture of compliance, accountability, collaboration, and continuous improvement.
Metrics & Continuous Improvement- Develop and monitor KPIs related to MDR compliance.
- Identify opportunities to streamline complaint handling and reporting processes.
- Lead quality improvement initiatives that enhance efficiency and compliance.
Technical Knowledge- FDA 21 CFR Part 803 (Medical Device Reporting), FDA Quality System Regulations and/or Quality Management System Regulation (QMSR), ISO 13485, ISO 14971 Risk Management, SOR/98-282 Health Canada Medical Device Regulations
- EU Medical Device Regulation (MDR) and post-market surveillance requirements preferred
- Complaint handling databases and electronic quality management systems (eQMS), experience with TrackWise Digital preferred
Soft Skills- Critical Thinking & Accountability: Makes sound, risk-based decisions, takes ownership of compliance and team performance, and drives issues to timely resolution.
- Collaboration & Relationship Management: Builds productive relationships with cross-functional teams, suppliers, and OEMs to resolve complex quality and regulatory challenges.
Physical Demands- Requires normal visual acuity and hearing.
- Typically, employees sit comfortably to do their work, interspersed by brief periods of standing, walking, bending, carrying papers and books, and extensive periods requiring the use of computer terminals to accomplish work objectives.
- Required to sit and use their hands and fingers to handle or feel and manipulate keys on a keyboard.
- Additional skills may be required to perform additional task(s) specific to work location, department or line of business.
Working Conditions- Predominantly operates in an office environment. Some work (less than 5%) requires moving and lifting of heavy networking equipment.
Pay Range: $90 - $120 per hour
