Senior Compliance Specialist at CVRx – Brooklyn Park, Minnesota

Senior Compliance Specialist

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 organizations quality system and post-market performance. This position also supports safety alerts, recalls, and broader post-market surveillance activities.Key Duties and 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

What we expect from you:

• 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

Working Conditions:

• Normal office conditions hybrid work environment available

• Must be able to sit/stand/walk 8 hours per day

• Position may require travel 1-2 times per year

• May be required to be fully vaccinated against the COVID-19 virus and other diseases

What we offerCVRx 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.
Salary range for U.S locations (USD): 100,000 - 115,000
The base salary range is applicable across the U.S., complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and specific location.
EEO STATEMENT CVRx, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
If you're an independent, self-motivated individual with excellent interpersonal skills, a desire to do great things and have a background in medical devices, healthcare or a related field, we want to hear from you!
If you need assistance or an accommodation due to a disability, you may contact us at hiring@cvrx.com
This requisition will be open until filled.