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CVRx | Barostim · 9 hours ago

Senior Compliance Specialist

Brooklyn Park, MN

Full-time

Hybrid

Mid, Senior Level

$100K/yr - $115K/yr

3+ years exp

CVRx pioneers unique therapies that harness the body's natural systems, making it a role model in healthcare. The Senior Compliance Specialist plays a critical role in safeguarding product quality and patient safety by leading the end-to-end complaint management process, ensuring compliance with regulatory requirements and driving improvements in the organization's quality system.

BiotechnologyHealth CareHealth DiagnosticsMedicalMedical Device

Growth Opportunities

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

Qualification

Complaint processingISO 13485FDA regulationsMDR standardsPost-Market SurveillanceCAPA implementationIndependenceAttention to detailWritten communicationVerbal communicationProblem-solvingAdaptability