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Regulatory Affairs Operations Manager Jobs in Raleigh, NC

NCBiotech

Director, Regulatory Affairs

Durham, NC · On-site

$130 - $160/hr

Director, Regulatory Affairs Department: Pharmaceutical Development About Pelthos: Pelthos ... Project Management * Ability to develop and execute regulatory strategies for drug development ...

Pelthos Therapeutics

Director, Regulatory Affairs

Durham, NC · On-site

$135K - $179K/yr

Director, Regulatory Affairs Department: Pharmaceutical Development About Pelthos: Pelthos ... Project Management * Ability to develop and execute regulatory strategies for drug development ...

Pelthos Therapeutics

Director, Regulatory Affairs

Durham, NC · On-site

$135K - $179K/yr

Director, Regulatory Affairs Department: Pharmaceutical Development About Pelthos: Pelthos ... Project Management * Ability to develop and execute regulatory strategies for drug development ...

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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 Sep 2, 2026, the average hourly pay for regulatory affairs operations manager in Raleigh, NC is $55.38, according to ZipRecruiter salary data. Most workers in this role earn between $40.91 and $64.71 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 near Raleigh, NC are hiring for Regulatory Affairs Operations Manager jobs?

Cities near Raleigh, NC with the most Regulatory Affairs Operations Manager job openings:

Regulatory Affairs Operations Manager jobs near you

Global Medical Affairs Operations Manager

Medela

Raleigh, NC

$140K/yr

Full-time

Medical, Retirement, PTO

Re-posted 6 days ago

Job description

Global Medical Affairs Operations Manager

Medela LLC

Salary starting at $140K

Travel 30%

Maternal & Infant Health | Global Programs | Medical Education | Real-World Evidence

At Medela, we are passionate about advancing maternal and infant health through evidence-based innovation, education, and healthcare partnerships. We are seeking a highly experienced Medical Affairs professional who is collaborative and operationally driven to be our Medical Affairs Operations Manager.

This person will lead the execution of global Medical Affairs programs, educational initiatives, and real-world evidence activities supporting healthcare professionals and customers worldwide.

This role is a critical connector across Medical Affairs, Clinical, Sales, Marketing, and external healthcare partners to ensure successful delivery of scientific and educational programs that improve outcomes in maternity and neonatal care.

What You'll Do

Lead Global Medical Affairs Operations

  • Manage the operational execution of global Medical Affairs programs, pilot initiatives, feasibility studies, and healthcare education programs
  • Oversee timelines, budgets, KPIs, reporting, tools, and stakeholder communications across multiple initiatives
  • Coordinate customer cohorts participating in education and intervention programs, ensuring strong execution and data collection
  • Drive continuous process improvement and operational excellence across Medical Affairs activities
  • Maintain and optimize systems supporting scientific communications, field education, and medical information management

Drive Real-World Evidence & Scientific Program Execution

  • Coordinate real-world evidence (RWE) initiatives and feasibility studies across healthcare customer sites
  • Track program outcomes, intervention effectiveness, quality improvement metrics, and customer adoption data
  • Develop evidence-based materials, case studies, and customer success stories highlighting clinical and operational outcomes
  • Partner cross-functionally with Medical Affairs, Clinical, Regulatory, and Marketing teams to execute evidence-generation strategies
  • Translate clinical insights into compliant, customer-facing tools and educational resources

Oversee Medical Education & Congress Operations

  • Lead operational planning and execution of global congresses, symposia, and medical education programs
  • Ensure educational content, speaker engagement, and scientific communications align with industry regulations and ethical standards
  • Oversee congress logistics, budgets, vendor management, timelines, and post-event reporting
  • Collaborate with internal stakeholders to align educational initiatives with organizational priorities

Lead & Develop a High-Performing Team

  • Foster collaboration across global and cross-functional teams
  • Operate effectively within a matrixed, global organization
  • Promote accountability, innovation, and continuous improvement

What You Bring as a Global Medical Affairs Professional

Qualifications

  • Experienced Medical Affairs professional
  • Bachelor's degree in Nursing, Life Sciences, Public Health, Nutrition Science, or related healthcare discipline required
  • Master's degree (MPH, MSN, MS, or equivalent) preferred
  • Strong understanding of maternal-infant health, NICU environments, lactation science, or infant nutrition
  • Knowledge of healthcare systems, clinical quality improvement frameworks, and medical education environments
  • Familiarity with industry compliance standards including MedTech Europe, AdvaMed, and GPP guidelines preferred
  • PMP certification or equivalent project management experience is a plus

Experience

  • 5+ years of experience in Medical Affairs, Clinical Operations, Healthcare Education, or related healthcare environments
  • Prior experience working directly within a Medical Affairs function required
  • Experience coordinating:
    • Real-world evidence initiatives
    • Feasibility studies
    • KOL engagement programs
    • Medical education initiatives
    • Scientific congress operations
  • Minimum 2 years of direct people leadership experience
  • Proven ability to manage complex cross-functional initiatives in a global environment
  • Experience with platforms such as Salesforce, SAP, Veeva, or KOL management tools is a plus
  • Travel: approximately 30%, including occasional international travel

Why Join Medela?

At Medela, you'll have the opportunity to make a meaningful impact on maternal and infant health globally while working alongside passionate experts dedicated to advancing evidence-based care, education, and innovation.

Join us in helping families and healthcare professionals achieve better outcomes worldwide.

What We Offer Our Global Medical Affairs Operations Manager

  • Competitive Salary Starting Salary of $140K
  • Comprehensive benefits plan
  • 401K with match
  • Pension Plan
  • 16-week Paid Parental Leave
  • Generous PTO package, plus 14 paid holidays
  • A great place to work!

This is not a job description. More details will be provided regarding the functions of this position.

If you are interested in this opportunity, we are looking forward to receiving your application.
For this position we only consider direct applications - thank you for your understanding.

As an EEO/Affirmative Action Employer, all qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, citizenship, sex, protected veteran status, age, physical or mental disability, medical condition, HIV/AIDs status, marital status, domestic partner status, sexual orientation, gender identity (transgender status), weight, height or any other characteristic protected by federal, state, or local law or ordinance.

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