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Regulatory Affairs Operations Manager Jobs (NOW HIRING)

MTF Biologics

Manager, Regulatory Affairs

Edison, NJ · On-site +1

$101K - $125K/yr

Responsible for the day-to-day leadership and operational management of the Regulatory Affairs function. This role oversees Regulatory Affairs personnel and ensures effective execution of U.S. and ...

MTF Biologics

Manager, Regulatory Affairs

Edison, NJ · On-site +1

$101K - $125K/yr

Overview Responsible for the day-to-day leadership and operational management of the Regulatory Affairs function. This role oversees Regulatory Affairs personnel and ensures effective execution of U.

Just Energy

Manager Regulatory Affairs

Austin, TX · Remote

Job Title: Regulatory Affairs Manager - Mass Markets South Location: Remote (Austin, Houston ... Serve as a day-to-day regulatory advisor to internal business partners across Operations ...

BeiGene, Ltd.

$119.78 - $149.72/hr

The successful candidate will oversee local Pharmaceutical Affairs operations, manage GxP compliance, and support regulatory inspections. This role requires strong leadership skills and a deep ...

Jobtailor

Regulatory Affairs Manager

Lake Forest, IL · On-site

$130 - $170/hr

* Manages the Regulatory Operations team responsible for various operational regulatory activities ... Regulatory Affairs Management * Medical Device Industry Experience * Regulatory Submissions ...

Medtronic

Sr Regulatory Affairs Manager

Lafayette, CO · On-site

A Day in the Life Senior Manager, Regulatory Affairs Operations & Technical Communications Careers That Change Lives The Senior Manager, Regulatory Affairs (RA) Operations & Technical Communications ...

Verathon, Inc.

Manager, Regulatory Affairs

Bothell, WA · On-site

$116.58 - $163.57/hr

This manager serves as the primary regulatory owner for FDA 510(k) submissions and global ... Translate Regulatory Affairs functional plans into operational processes, contribute to annual ...

Oterra

Regulatory Affairs Manager

Mount Pleasant, WI · On-site

... Operations, and Global Regulatory teams. The Regulatory Affairs Manager will drive regulatory strategies that enable successful commercialization of new color technologies, support customer ...

Abbott

Regulatory Specialist Sr

Lakeside, CA · On-site

... operational planning, resource allocation, and management reporting. Qualifications * Bachelor's degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, Engineering, or related ...

Oterra

Regulatory Affairs Manager

Mount Pleasant, WI · On-site

... Operations, and Global Regulatory teams. The Regulatory Affairs Manager will drive regulatory strategies that enable successful commercialization of new color technologies, support customer ...

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Regulatory Affairs Operations Manager information

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

As of Aug 12, 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 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.

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 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 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 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

Manager, Regulatory Affairs

MTF Biologics

Edison, NJ • On-site, Remote

$101K - $125K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 2 days ago

MTF Biologics rating

9.2

Company rating: 9.2 out of 10

Based on 13 frontline employees who took The Breakroom Quiz

Job description

Responsible for the day-to-day leadership and operational management of the Regulatory Affairs function. This role oversees Regulatory Affairs personnel and ensures effective execution of U.S. and international regulatory activities, including regulatory submissions, inspections and audits, recalls, licensing, labeling and promotional review, quality system documentation, risk management, and design control support. Ability to travel up to 20% of time to MTF locations and to suppliers as required

Monday through Friday 8:15am to 4:30pm

Salary Range : $101,000- $125,000/yr. 


  • Lead, coach, and develop Regulatory Affairs staff, including staffing plans, performance management, training, and competency maintenance. Also performs active management and observations of staff for compliance with regulations and process efficiencies.
  • Assist in managing the budget for Regulatory Affairs department, including salaries, benefits, external vendors/consultants, supplies, services and internal expenses. Responsible for formulating/submitting budgets and managing to expense within budget requirements. Tracks monthly "budget to actual" performance.
  • Oversee and assist in the preparation, submission, and maintenance of U.S. and international regulatory filings (FDA, CE Marking, Canada, Australia, and other global markets).
  • Ensure maintenance of all applicable licenses, accreditations (AATB), and ISO 9001 / 13485 certifications.
  • Participates in the development of regulatory strategies and pathway to support the regulatory designation of new products and tissues.
  • Serve as a primary regulatory contact during inspections and audits and lead regulatory intelligence activities.
  • Communicates and coordinates with VP and MTF senior management and other department heads on regulatory issues and regulatory strategies which may impact MTF's ability to fulfill its mission.
  • Communicates with federal/state regulatory agencies, international government and notified bodies, and AATB related to applicable new or revised regulations and standards
  • Assist on special projects and performs additional duties as assigned.

  • Bachelor's degree in a scientific or related field, or a combination of education and equivalent work experience
  • 7+ Years of overall experience
  • 5 Years of Managerial experience
  • 5 Years or Human tissue or medical device manufacturing
  • Thorough understanding of FDA, QSR, cGMP, ISO regulations for medical devices, diagnostics or pharma Must exhibit people management, effective communication skills
  • Attention to detail, critical thinking, problem-solving, and organizational skills
  • Prior experience handling FDA inspections for medical devices, diagnostics, biologics and/or pharma Demonstrated success in obtaining US FDA regulatory clearance/approval for medical technologies
  • Ability to travel up to 20% of time to MTF locations and to suppliers as required

At MTF Biologics we provide comprehensive benefits and resources to support our employees physical, emotional, and financial health.

  • 4 weeks Paid Time Off (PTO)
  • Paid Holidays
  • Medical, Dental,  Vision Insurance and Prescription Drug Insurance
  • 401K plan with company match
  • Short & Long Term Disability
  • Life & Accidental Death Insurance
  • Tuition Reimbursement
  • Health Care/Dependent Care Flexible Spending Accounts
  • Adoption Assistance
  • Voluntary Benefits (e.g., Pet Insurance, Legal, home and auto insurance)
  • Sword Health (at home Physical Therapy)

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