Senior Compliance Specialist

CVRx, Inc. • Brooklyn Park, MN

2d • Hybrid

About The Position

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.

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

Benefits

• CVRx is proud to offer competitive salaries and benefits plans.
• We offer a culture of teamwork, collaboration, and positivity, where challenging the status quo is welcomed, continuous learning is valued, and each of us has an opportunity to make a significant impact in an exciting, purpose-driven startup environment while also having fun.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level