Senior Compliance Specialist

CVRx•Brooklyn Park, MN

5h•Hybrid

About The Position

Why work for CVRx? CVRx pioneers' unique therapies that harness and harmonize the body's natural systems, benefiting society and making CVRx a universal role model in healthcare. We value our commitments to others and continue to overcome challenges through determination, collaboration, and purpose. If our culture and values speak to you, and if you have a passion for cutting-edge medical technologies, join our team and our mission to help others live better lives. A day in the life: The Senior Compliance Specialist plays a critical role in safeguarding product quality and patient safety by leading the end-to-end complaint management process. This role serves as a central connector across teams, ensuring complaints are handled thoroughly, consistently, and in alignment with regulatory and internal requirements. The Senior Compliance Specialist partners closely with cross-functional stakeholders to uncover trends, address risk, and drive meaningful improvements that strengthen the organization’s quality system and post-market performance. This position also supports safety alerts, recalls, and broader post-market surveillance activities.

Requirements

College degree or equivalent experience
3-5 years’ experience with complaint processing
Solid understanding of ISO 13485, FDA, and MDR standards and regulations
Strong attention to detail with advanced written and verbal communication skills
Effective problem-solver who can manage multiple priorities
Adaptable, resourceful, and able to work independently

Responsibilities

Coordinate the full complaint lifecycle, including intake, tracking, investigation, and closure, working closely with cross-functional partners
Ensure complaints are accurately documented, appropriately categorized, and progressed within required regulatory and internal timelines
Review complaint responses for accuracy, completeness, clarity, tone, and regulatory compliance prior to finalization
Monitor complaint data to identify trends, potential root causes, and emerging risks; support cross-functional teams in identifying and tracking corrective and preventive actions
Facilitate monthly complaint review meetings by preparing metrics, dashboards, and summary reports for leadership, compliance committees, and regulatory audiences
Support the maintenance and continuous improvement of complaint-related policies, procedures, workflows, and internal controls
Assist with the evaluation, documentation, and reporting of safety alerts and recalls, as applicable
Support Post-Market Surveillance activities, including contributions to Periodic Safety Update Reports (PSURs).
Participate in CAPA review meetings and support timely CAPA implementation and closure activities
Obtain internal auditor certification and assist with internal audits and, as appropriate, supplier audits
Provide support for regulatory submissions and responses, as needed
Perform additional responsibilities as assigned by management