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Regulatory Affairs Operations Manager Jobs (NOW HIRING)

Unicity

Regulatory Affairs Manager

Provo, UT · On-site

Regulatory Affairs Manager Provo, Utah In-office About the Company Unicity was founded with a bold ... Operational Efficiency: Proven ability to streamline workflows, reduce bottlenecks, and replace ...

Jj

Regulatory Affairs Manager

Raynham, MA · On-site

Provide Regulatory Affairs support during internal and external audits * Responsible for communicating business related issues or opportunities to next management level * Responsible for following ...

Dentsply Sirona

Regulatory Affairs Manager

The primary job responsibility for of the Regulatory Affairs Manager is overseeing the day-to-day functions of the Dentsply Sirona Implants and Prosthetics team. This role develops regulatory ...

Dentsply Sirona, Inc

Regulatory Affairs Manager

The primary job responsibility for of the Regulatory Affairs Manager is overseeing the day-to-day functions of the Dentsply Sirona Implants and Prosthetics team. This role develops regulatory ...

Jj

Regulatory Affairs Manager

Palm Beach Gardens, FL

Provide Regulatory Affairs support during internal and external audits * Responsible for communicating business related issues or opportunities to next management level * Responsible for following ...

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

As of Jul 15, 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, and why are they important?

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
Regulatory Affairs Intelligence Specialist

Regulatory Affairs Intelligence Specialist

Abbott

Saint Paul, MN • On-site

Full-time

Medical, Retirement

Re-posted 13 days ago

Abbott rating

7.9

Company rating: 7.9 out of 10

Based on 136 frontline employees who took The Breakroom Quiz

157th of 527 rated manufacturers

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
Working at Abbott
  • At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:

  • Career development with an international company where you can grow the career you dream of.

  • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

  • An excellent retirement savings plan with a high employer contribution

  • Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.

  • A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.

  • A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity
This position serves as the Medical Devices Regulatory Affairs (RA) Global Regulatory Compliance process lead; collaborates cross-functionally as needed and keeps MD RA informed of key global regulatory changes and status of assessment / implementation for compliance via the QMS Process.
WHAT YOU'LL DO
Global Regulatory Operations is seeking a Regulatory Affairs Intelligence Specialist to join our team in St. Paul, MN.
This position is focused on new and changing regulations that enable global market access for new and innovative medical devices and supports compliance continuity for marketed devices. Assisting in the process to evaluate proposed regulatory changes in major markets including the US, EU, Canada, Australia, Brazil, Japan, the Regulatory Affairs Intelligence Specialist:
  • Monitors and fact-checks new or changing global regulations

  • Tracks and documents regulations within the regulatory intelligence systems

  • Supports the communication of emerging regulations, documents for comment, and regulations in implementation

  • Performs regulatory investigations to assess medical device regulatory changes within a specific country or region

  • Supports the maintenance of, or continuous improvement of quality system procedures, and documents

  • May train others on systems and processes

  • Facilitates the collection and reporting of data in support of key performance indicators

  • Gathers additional data to support interpretation, and aid businesses in determining impact

  • Support all company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements

  • Complies with regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments.

  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, etc.

  • Performs other related duties and responsibilities, on occasion, as assigned

Required Qualifications
  • Bachelors Degree (± 2 years) In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred OR an equivalent combination of education and work experience

  • Minimum 2 years This position does not require previous regulatory experience. 2-3 years experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.

  • Experience with Regulatory history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel; Principles and requirements of applicable product laws; Submission/registration types and requirements; GxPs (GCPs, GLPs, GMPs); Principles and requirements of promotion, advertising and labeling; Domestic and international regulatory guidelines, policies and regulations; Ethical guidelines of the regulatory profession, clinical research and regulatory process. Note: This knowledge may be developed through tenure in this position.

  • Communicate effectively verbally and in writing. Communicate with diverse audiences and personnel. Write and edit technical documents.

  • Work with cross-functional teams. Work with people from various disciplines and cultures.

  • Write and edit technical documents.

  • Negotiate internally.

  • Pay strong attention to detail.

  • Manage projects. Create project plans and timelines.

  • Think analytically and critically.

  • Organize and track complex information.

  • Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

  • Has a sound knowledge of a variety of alternatives and their impact on the business.

  • Apply business and regulatory ethical standards.

  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.

Preferred Qualifications
  • 2-4+ years' experience in medical devices, or a regulated industry (e.g., nutritional, pharma) preferred. Experience in a Regulatory or Quality role, a plus.

  • Ability to work within a fast-paced and matrixed team environment

  • Strong verbal and written communication skills • Strong attention to detail and organizational skills

  • Proficient in Excel, and all programs with MS Office suite (Word, PowerPoint, Outlook)

  • Experience in program management a plus

  • Experience with document management systems a plus

The base pay for this position is
$61,300.00 - $122,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
AVD Vascular
LOCATION:
United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 5 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

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