Senior Compliance Specialist
CVRx | Barostim, Brooklyn Park, MN, United States
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.
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.
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 offer 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.
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.
Health & Dental Insurance options with generous company contributions
Company contributions to an HSA if enrolled in a high‑deductible plan
401(k) with company match
Employee stock purchase plan & stock option grants
12 company‑paid holidays per year + PTO
Paid time off for new parents
Company‑paid life insurance & disability
Unlimited growth opportunities
Training & learning opportunities
Flexible schedules
Compensation and benefits information pertain solely to candidates hired in the United States.
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.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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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.
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 offer 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.
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.
Health & Dental Insurance options with generous company contributions
Company contributions to an HSA if enrolled in a high‑deductible plan
401(k) with company match
Employee stock purchase plan & stock option grants
12 company‑paid holidays per year + PTO
Paid time off for new parents
Company‑paid life insurance & disability
Unlimited growth opportunities
Training & learning opportunities
Flexible schedules
Compensation and benefits information pertain solely to candidates hired in the United States.
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.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
#J-18808-Ljbffr