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Quality Regulatory Manager Jobs (NOW HIRING)

Emerus

Hospital Regulatory Manager

Position Overview The Hospital Regulatory Manager leads and coordinates regulatory readiness ... This position partners with quality and operational leaders to promote continuous readiness ...

Ferrara

International Regulatory Manager

Chicago, IL · On-site

... high-quality products to consumers around the world. Ways you will make a difference Team ... Report on Regulatory management metrics, including international product compliance and progress on ...

Emerus

Position Overview The Hospital Regulatory Manager leads and coordinates regulatory readiness ... This position partners with quality and operational leaders to promote continuous readiness ...

Astrix Inc

Safety & Regulatory Manager

New York, NY · On-site

$36 - $40/hr

Partner cross-functionally with R&D, Packaging, Marketing, Quality, and Supply Chain teams ... Experience managing investigations, adverse event reporting, and regulatory documentation * Hands ...

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Quality Regulatory Manager information

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$24K

$86.2K

$158K

How much do quality regulatory manager jobs pay per year?

As of Jun 10, 2026, the average yearly pay for quality regulatory manager in the United States is $86,159.00, according to ZipRecruiter salary data. Most workers in this role earn between $44,000.00 and $136,000.00 per year, depending on experience, location, and employer.

What is the difference between Quality Regulatory Manager vs Quality Assurance Specialist?

AspectQuality Regulatory ManagerQuality Assurance Specialist
CertificationsISO 13485, Regulatory Affairs certificationsISO 9001, QA certifications
Work EnvironmentRegulatory agencies, compliance departmentsManufacturing, production, quality labs
Employer & Industry UsageMedical devices, pharmaceuticals, biotechManufacturing, consumer products, electronics

The Quality Regulatory Manager focuses on ensuring products meet regulatory standards and manages compliance documentation, often working closely with regulatory agencies. In contrast, the Quality Assurance Specialist primarily ensures product quality through testing and process audits. Both roles require quality certifications but differ in their focus areas and work environments.

How does a Quality Regulatory Manager typically collaborate with cross-functional teams to ensure compliance?

A Quality Regulatory Manager works closely with departments such as manufacturing, R&D, and supply chain to interpret and implement regulatory requirements across the organization. Regular meetings and clear communication are essential to align quality systems with evolving regulations and address compliance gaps. The manager often leads training sessions, reviews documentation, and coordinates audits, ensuring all teams understand and adhere to quality standards. This collaborative approach helps maintain product safety and supports successful regulatory submissions.

What is a Quality Regulatory Manager?

A Quality Regulatory Manager is a professional responsible for ensuring that a company's products and processes comply with industry regulations, standards, and quality requirements. They oversee the implementation of quality management systems, prepare for regulatory audits, and keep the organization updated on changing regulations. This role often involves working closely with various departments to ensure documentation, processes, and products meet both internal and external compliance standards. Quality Regulatory Managers play a critical part in maintaining the company's reputation and ability to operate within legal guidelines.

What are the key skills and qualifications needed to thrive as a Quality Regulatory Manager, and why are they important?

To thrive as a Quality Regulatory Manager, you need in-depth knowledge of quality management systems, regulatory compliance, and industry standards, typically backed by a relevant degree and experience in regulated environments. Familiarity with ISO standards, FDA regulations, audit management tools, and certifications like CQE or RAC is highly valued. Strong analytical thinking, attention to detail, and effective communication are critical soft skills for collaborating across departments and ensuring compliance. These skills and qualifications are essential to maintain product quality, meet regulatory requirements, and mitigate compliance risks within an organization.
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Quality Regulatory Manager jobs near you
Quality & Regulatory Director

Quality & Regulatory Director

Nuwellis, Inc

Eden Prairie, MN • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 15 days ago

Job description

Job Type
Full-time
Description
About Nuwellis
Nuwellis, Inc. is a medical device company focused on improving the lives of patients suffering from fluid overload through our Aquadex SmartFlow ultrafiltration therapy. Our team is passionate about developing technology that helps clinicians treat critically ill patients more effectively.
The Opportunity
We are seeking a Quality & Regulatory Director to lead Nuwellis Quality & Regulatory, direct day-to-day operation of the Quality Management System, and serve as Nuwellis' in-house regulatory expert for US, EU, and global compliance.
Quality - This role is responsible for implementation and maintenance of Quality System procedures related to oversight of contract manufacturing, operations, document and record control, customer feedback/complaint handling, and internal and external audits to assure compliance to Quality System Regulations (QSR), ISO, and other applicable requirements.
Regulatory - This role leads the development of regulatory strategy, preparation of submissions, supports new product development, maintains regulatory compliance of products/organization and interfaces with worldwide regulatory bodies.
*This role is ideal for someone to be an individual contributor as well as a strategic leader.*
This position requires prior experience working in a regulated medical device environment and hands-on experience with FDA Quality System Regulations and ISO 13485.
This is an onsite position, requiring a full-time in-person presence at Nuwellis' corporate office in Eden Prairie, MN.
What You Will Do
  • Hands on Quality Leader responsible for the overall Quality Systems and Regulatory compliance (e.g. ISO 138485, QMSR).
  • Manage Document and Record Control, training, CAPA, Change Control and Feedback and Complaint Systems.
  • Ensure Corrective Actions are comprehensive, effective and timely.
  • Maintain working knowledge of existing and emerging regulations, standards and guidance documents applicable to the business (including interpretation, communication of potential impact to senior leadership, and assisting in implementing actions to assure compliance).
  • Develop quality plans to ensure corporate and compliance objectives are met.
  • Oversight and management of supplier quality to support supplier selection and approval, audits and CAPA.
  • Identify and analyze quality trends and propose and implement strategies and projects to maximize and optimize overall quality performance.
  • Act as regulatory representative in internal and external meetings.
  • Assist in ensuring the company is in a constant state of readiness for regulatory inspections. Lead role in management of regulatory agency inspections and certification/accreditation body audits.
  • Develop regulatory strategy and identify deliverables for new product submissions and design changes as appropriate.
  • Prepare FDA and other worldwide regulatory submissions (e.g. applications, IDE Supplements, Design Dossier Amendments, Annual Reports, etc.) and other regulatory related documentation.
  • Resolve potential regulatory issues and questions from regulatory agencies. Negotiate submission issues with agency personnel.
  • Provide support for currently marketed products, including review of engineering changes, process changes, and labeling changes.
  • Maintain regulatory systems that overlap with Quality Systems, such as complaint handling and reporting, implant/tracking registries, and labeling.
  • General Management Responsibilities: Interviewing, hiring, training and developing employees; establishing and communicating expectations; planning, monitoring, and appraising job results; rewarding, coaching, and disciplining employees; addressing concerns and resolving problems; developing, coordinating, and enforcing systems, policies, procedures, and productivity standards.

Requirements
What You Will Bring
Required Qualifications
  • Bachelor's degree in a technical field or scientific discipline.
  • 10+ years of experience in the medical device industry with class II or class III products, with 5+ years of experience leading people, projects, programs and/or departments.
  • Experience with overseeing contract manufacturing and product acceptance requirements.
  • Significant experience with ISO 13485.
  • Ability to think independently and make sound strategic quality and regulatory decisions.
  • Ability and willingness to work on-site in Eden Prairie, MN.
  • Must be eligible to work in the U.S. without employer sponsorship.

Preferred Qualifications / Success Factors
  • Previous direct managerial experience strongly preferred.
  • Demonstrable direct and effective working relationship with worldwide regulatory bodies.
  • Demonstratable experience developing and interpreting standards, guidelines and special controls.
  • Extensive knowledge of standards and regulations with ability to integrate into projects.
  • ASQ CQE or other similar quality or regulatory certification.
  • Demonstrated ability to develop strong and appropriate consultant relationships.
  • Grand Avenue Software experience a plus.

Compensation & Benefits
Salary Range: $150,000-$183,000
We offer competitive pay (dependent on qualifications and experience) and a comprehensive benefits package, including:
  • Annual discretionary bonus
  • Health insurance (multiple plan options), including an HDHP with an annual company contribution of $2,000 (individual) / $4,000 (family)
  • Company contribution toward dental and vision coverage
  • Employer-paid life insurance (up to 1x annual salary), short- and long-term disability, and PFML
  • Paid time off including PTO, floating holidays, and 8 company holidays
  • 401(k) plan with a 3% company match

Ready to Apply?
Does this sound like you? Let's talk.
Please submit your resume for consideration. While we may not be able to respond to every applicant individually, qualified candidates can expect follow-up within approximately three business days.
Any offer of employment is contingent upon successful completion of a background check and drug screening.
Equal Opportunity Employer:
Nuwellis provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other protected status.

Apply