MDR – MDR/VIGILANCE SPECIALIST

Location: Mounds View, MN – on-site contract role.

About the role

Individual contributor within the Quality and Compliance team, specializing in medical-device vigilance. Supports the company’s cardiovascular surgery product portfolio by ensuring accurate intake, evaluation, processing, and regulatory reporting of adverse events. Acts as an internal and external liaison to develop and maintain compliant surveillance programs.

Responsibilities

• Monitor the company’s medical-device surveillance program, including intake, protocol development, evaluation, processing, and follow-up on adverse reports.
• Ensure complete and accurate maintenance and reporting of Medical Device Reports (MDRs) and other adverse-event data to regulatory agencies.
• Review and analyze clinical databases to extract adverse-event data and integrate it into a unified, standardized database.
• Map complaint codes to regulatory categories and update Work Instructions accordingly.
• Collaborate with cross-functional teams to meet regulatory reporting requirements and resolve legal-liability issues.
• Deliver and oversee projects from design to implementation, adhering to internal policies and using specialized knowledge.
• Provide guidance to entry-level professionals and support staff as needed.

Requirements

• University degree (advanced education preferred).
• Minimum of 2 years of relevant experience; target range is 3–5 years.
• Experience handling medical-device complaints.
• Knowledge of IMDRF or complaint coding is a plus.
• Project-management experience.