ZipRecruiter

Log In

1

Regulatory Affairs Operations Manager Jobs (NOW HIRING)

Kite Pharma

Manager, Regulatory Affairs

The PRC Operations team under Regulatory Affairs Advertising and Promotion serves as a strategic ... Manage submission timelines and collaborate with cross-functional teams to ensure accurate and ...

New

Edwards Lifesciences

Regulatory Affairs

Edwards, CO · On-site

$120 - $180/hr

... Operations - Execution and management of regulatory processes * Lead and support preparation of ... AnaghaSenior Director, TMTT (US) \"Being part of Regulatory Affairs gives me tremendous opportunity ...

New

Medtronic

Regulatory Affairs Specialist

Memphis, TN · On-site

Minimum 2 years of experience in Regulatory Affairs, Regulatory Operations, Data Analytics, Data Management, or related function. * Experience analyzing large datasets and translating findings into ...

next page

Showing results 1-20

All JobsGovernment JobsGovernment Services JobsRegulatory Affairs Operations Manager Jobs

Regulatory Affairs Operations Manager information

See salary details

$28

$56

$86

How much do regulatory affairs operations manager jobs pay per hour?

As of Sep 2, 2026, the average hourly pay for regulatory affairs operations manager in the United States is $56.97, according to ZipRecruiter salary data. Most workers in this role earn between $42.07 and $66.59 per hour, depending on experience, location, and employer.

What does a Regulatory Affairs Operations Manager do?

A Regulatory Affairs Operations Manager oversees the processes and systems that ensure a company's products comply with all relevant regulations and standards. They coordinate regulatory submissions, manage documentation, and ensure timely communication with regulatory agencies. Additionally, they often supervise teams, develop efficient workflows, and implement best practices to support regulatory compliance throughout the product lifecycle.

What are the key skills and qualifications needed to thrive as a Regulatory Affairs Operations Manager?

To thrive as a Regulatory Affairs Operations Manager, you need expertise in regulatory compliance, project management, and a relevant scientific or technical degree, often supported by experience in pharmaceuticals or medical devices. Familiarity with regulatory submission systems (e.g., eCTD), document management tools, and knowledge of global regulatory guidelines are crucial. Exceptional organizational, leadership, and communication skills help you manage cross-functional teams and coordinate complex processes. These competencies ensure efficient regulatory submissions, reduce compliance risks, and support timely product approvals.

What are some common challenges faced by Regulatory Affairs Operations Managers, and how can they be addressed?

Regulatory Affairs Operations Managers often navigate complex, constantly changing regulations across multiple regions and product lines, which can make staying compliant challenging. Managing tight submission timelines while coordinating with cross-functional teams such as R&D, Quality, and Legal requires strong organizational and communication skills. Implementing robust digital tracking systems and fostering close collaboration with internal stakeholders can help streamline processes and reduce the risk of errors or delays. Continuous professional development and networking with industry peers also support staying up-to-date with regulatory trends.

What is the difference between Regulatory Affairs Operations Manager vs Regulatory Affairs Specialist?

AspectRegulatory Affairs Operations ManagerRegulatory Affairs Specialist
CredentialsBachelor's degree, often with certifications like RACBachelor's degree, often with certifications like RAC
Work EnvironmentOversees teams, manages processes, strategic planningExecutes regulatory submissions, prepares documentation
Employer & Industry UsageUsed in pharmaceutical, biotech, medical device companiesCommon in similar industries, more focused on technical tasks
Search & Comparison IntentUnderstanding managerial roles in regulatory operationsDetailing specific regulatory tasks and responsibilities

The Regulatory Affairs Operations Manager oversees regulatory processes and manages teams, focusing on strategic planning and compliance management. In contrast, the Regulatory Affairs Specialist handles specific regulatory submissions and documentation tasks. Both roles require similar credentials but differ in scope and responsibilities within the regulatory department.

How much do regulatory affairs managers make in the US?

Regulatory Affairs Managers in the US typically earn between $90,000 and $150,000 annually, with median salaries around $120,000. Compensation varies based on experience, industry, location, and certifications such as RAC, and often includes benefits like bonuses and health insurance.

What cities are hiring for Regulatory Affairs Operations Manager jobs?

Cities with the most Regulatory Affairs Operations Manager job openings:

What states have the most Regulatory Affairs Operations Manager jobs?

States with the most job openings for Regulatory Affairs Operations Manager jobs include:

Regulatory Affairs Operations Manager jobs near you

REGULATORY AFFAIRS OPERATIONS MANAGER

UW Medicine

Seattle, WA • On-site

$110 - $170/hr

Other

Posted 3 days ago

New

UW Medicine rating

8.0

Company rating: 8.0 out of 10

Based on 45 frontline employees who took The Breakroom Quiz

89th of 898 rated healthcare providers

Job description

Harborview Medical Center Quality Assurance has an outstanding opportunity for a Clinical Program Operations Manager of Regulatory Affairs.

WORK SCHEDULE

100% FTE

100% Onsite

POSITION HIGHLIGHTS

This position serves as an expert resource and partner for content experts throughout the organization on accreditation, hospital licensure, department of health requirements and a variety of other pertinent healthcare regulations and standards.

PRIMARY JOB RESPONSIBILITIES
  • Ensures all regulatory & accrediting body program objectives and requirements are achieved.
  • Proactively leads hospital-wide preparation for regulatory body surveys and investigations, ensuring continuous preparedness.
  • Facilitates regulatory body surveys and investigations.
  • Develops corrective action plans for deficiencies cited during surveys and investigations, and devises measures of success for ongoing future compliance.
  • Monitors and audits hospital-wide performance on all regulatory and accrediting body requirements at the federal and state level.
  • Develops tools for conducting individual audits, tracers and assessment surveys throughout HMC, with emphasis on pertinent healthcare regulations and standards. Provides executive and operational leadership with real time feedback on elements of performance.
  • Consults on and assists with interpreting regulatory standards.
  • Develops projects related to process improvement and regulatory requirements throughout HMC, by collaboratively working with senior leadership, upper-management and staff to facilitate their training, deployment, implementation and evaluation.
  • Collaborates with stakeholders and data system owners in order to ensure quality timeliness of reports, benchmarks, and measures.
ABOUT UW MEDICINE – WHERE YOUR IMPACT GOES FURTHER

UW Medicine is Washington’s only health system that includes a top-rated medical school and an internationally recognized research center. UW Medicine’s mission is to improve the health of the publicby advancing medical knowledge, providing outstanding primary and specialty care to the people of the region, and preparing tomorrow’s physicians, scientists and other health professionals.

All across UW Medicine, our employees collaborate to perform the highest quality work with integrity and compassion and to create a respectful, welcoming environment where every patient, family, student and colleague is valued and honored. Nearly 29,000 healthcare professionals, researchers, and educators work in the UW Medicine family of organizations that includes: Harborview Medical Center, UW Medical Center - Montlake, UW Medical Center - Northwest, Valley Medical Center, UW Medicine Primary Care, UW Physicians, UW School of Medicine, and Airlift Northwest.

Become part of our team. Join our mission to make life healthier for everyone in our community.

ABOUT HARBORVIEW MEDICAL CENTER

As the region's only Level I Trauma and verified burn center, Harborview Medical Center is a comprehensive healthcare facility owned by King County and operated by UW Medicine. It is dedicated to providing specialized care for a broad spectrum of patients from throughout the Pacific Northwest, including the most vulnerable residents of King County. It provides exemplary patient care in leading-edge centers of emphasis, including emergency medicine, trauma and burn care, neurosciences, ophthalmology, vascular surgery, HIV/AIDS, rehabilitation, mental health and substance abuse care.

Harborview employees are committed to the vital role the institution plays in the immediate community, as well as the entire Northwest region.

Challenge. Collaboration. Compassion.

  • BA or BS in Nursing or equivalent field, with 6-8+ years of clinical experience
  • Experience in inpatient acute or critical care settings
  • An equivalent combination of education and experience will be considered
#J-18808-Ljbffr

What UW Medicine employees say

Pay

Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom

Apply