ZipRecruiter

Log In

1

Regulatory Affairs Operations Jobs (NOW HIRING)

Abbott

Regulatory Specialist Sr

Lakeside, CA · On-site

We are seeking a highly skilled and experienced Regulatory Affairs Senior Specialist to join the Regulatory Affairs Operations team. This individual will serve as a key contributor to the centralized ...

Abbott

Regulatory Specialist Sr

Lakeside, CA · On-site

We are seeking a highly skilled and experienced Regulatory Affairs Senior Specialist to join the Regulatory Affairs Operations team. This individual will serve as a key contributor to the centralized ...

Just Energy

Manager Regulatory Affairs

Austin, TX · On-site

The position is primarily focused on Texas retail regulatory affairs, while also providing support on wholesale regulatory matters that affect the company's retail operations and additional ...

Just Energy

Manager Regulatory Affairs

Austin, TX · Remote

The position is primarily focused on Texas retail regulatory affairs, while also providing support on wholesale regulatory matters that affect the company's retail operations and additional ...

Oscar Health

Analyst, Regulatory Affairs

Tempe, AZ

$28.30 - $37.15/hr

We're hiring a Analyst, Regulatory Affairs to join our Regulatory Affairs team. Oscar is the first ... Familiarity with health insurance operations * Experience with the individual market health ...

previous pagenext page

Showing results 21-40

All JobsRegulatory Affairs Operations Jobs

Regulatory Affairs Operations information

See salary details

$18

$39

$62

How much do regulatory affairs operations jobs pay per hour?

As of Aug 12, 2026, the average hourly pay for regulatory affairs operations in the United States is $39.57, according to ZipRecruiter salary data. Most workers in this role earn between $31.73 and $46.88 per hour, depending on experience, location, and employer.

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

To thrive in Regulatory Affairs Operations, you need a strong understanding of regulatory guidelines, document management, and compliance procedures, often backed by a degree in life sciences or a related field. Familiarity with regulatory submission platforms, electronic document management systems (EDMS), and certifications such as RAC (Regulatory Affairs Certification) are typically important. Exceptional attention to detail, organizational skills, and effective communication help you excel in managing complex regulatory documentation and stakeholder interactions. These skills are critical to ensure accurate, timely submissions and ongoing compliance with global regulatory requirements.

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

AspectRegulatory Affairs OperationsRegulatory Affairs Specialist
CredentialsTypically requires a degree in life sciences or related field; certifications like RAC are commonSame as Regulatory Affairs Operations, often requiring similar certifications
Work EnvironmentFocuses on process management, documentation, and compliance activities within regulatory teamsInvolves preparing submissions, liaising with authorities, and ensuring product compliance
Employer & Industry UsageUsed across pharmaceutical, biotech, and medical device companies for operational supportCommonly used in similar settings for product-specific regulatory tasks

Regulatory Affairs Operations roles focus on managing regulatory processes and documentation, ensuring smooth compliance workflows. Regulatory Affairs Specialists handle product submissions and communication with regulatory agencies. Both roles require similar credentials and work environments but differ in their primary responsibilities within the regulatory process.

What is Regulatory Affairs Operations?

Regulatory Affairs Operations refers to the processes, systems, and teams that support regulatory affairs activities in industries such as pharmaceuticals, biotechnology, and medical devices. This function focuses on ensuring that regulatory submissions, documentation, and compliance activities are managed efficiently and in accordance with global regulatory requirements. Regulatory Affairs Operations professionals handle document management, submission planning, and electronic regulatory systems, enabling organizations to gain and maintain product approvals. Their work is critical for meeting deadlines, maintaining compliance, and facilitating communication with regulatory agencies.

What are some common challenges faced by professionals in Regulatory Affairs Operations, and how can they be managed?

Professionals in Regulatory Affairs Operations often navigate rapidly changing regulations and tight submission deadlines, which can be challenging. Staying organized and proactive in monitoring regulatory updates is critical. Effective collaboration with cross-functional teams, such as clinical, quality, and legal departments, helps ensure timely and accurate regulatory submissions. Leveraging project management tools and maintaining clear communication channels can also help manage workload and maintain compliance.
More about Regulatory Affairs Operations jobs
What cities are hiring for Regulatory Affairs Operations jobs? Cities with the most Regulatory Affairs Operations job openings:
What are the most commonly searched types of Regulatory Affairs Operations jobs? The most popular types of Regulatory Affairs Operations jobs are:
What states have the most Regulatory Affairs Operations jobs? States with the most job openings for Regulatory Affairs Operations jobs include:
What job categories do people searching Regulatory Affairs Operations jobs look for? The top searched job categories for Regulatory Affairs Operations jobs are:
Regulatory Affairs Operations jobs near you
Infographic showing various Regulatory Affairs Operations job openings in the United States as of August 2026, with employment types broken down into 86% Full Time, 11% Part Time, 1% Temporary, and 2% Contract. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.

Associate Specialist, Regulatory Affairs Operations TMTT

Edwards Lifesciences Corporation

California, MD • Hybrid

$59K - $83K/yr

Full-time

Posted 8 days ago

Edwards Lifesciences rating

8.3

Company rating: 8.3 out of 10

Based on 30 frontline employees who took The Breakroom Quiz

67th of 538 rated manufacturers

Job description

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients' lives.

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you will make an impact:

  • Develop routine Regulatory Affairs process improvement initiatives including system enhancements, training reports, and/or dashboards
  • Execute the coordination of submissions deliverables, schedule and tracking of appendices and documents
  • Prepare compilation and publication of paper and electronic documentation packages for submission to global regulatory agencies in collaboration with team members
  • Support management, retrieval, archival, and maintenance of regulatory records and submission documentation in accordance with applicable procedures and regulatory requirements
  • Maintain regulatory systems, databases, and tracking tools to ensure accuracy, completeness, and data integrity of regulatory information
  • Review and/or interpret standard assessments to ensure product compliance
  • Interact effectively within the regulatory affairs team in the preparation of documentation packages, supporting team and company goals and objectives
  • Prepare for regulatory agency inspections and audits (e.g., track RA plans and changes, understanding requirements)

What you will need (Required):

  • Bachelor's Degree or equivalent work experience based on Edwards criteria
  • Coursework, seminars, and/or other formal government and/or trade association training or equivalent work experience based on Edwards criteria

What else we look for (Preferred):

  • Bachelor's Degree in a scientific discipline (e.g., Biology, Microbiology, Chemistry) or equivalent work experience based on Edwards criteria
  • Experience working in a regulated industry
  • Proven successful project management leadership skills
  • Proven expertise in Microsoft Office Suite and related tools and systems
  • Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
  • Ability to develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness
  • Strict attention to detail
  • Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
  • Good knowledge and understanding of global regulations relevant to medical devices (e.g., Class I, Class II and/or Class III devices)
  • Good knowledge and understanding of global regulatory requirements for new products or product changes

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $59,000 - $83,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

#LI-Hybrid


Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

What Edwards Lifesciences employees say

Pay

Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom

Edwards Lifesciences logo

About Edwards Lifesciences

Sourced by ZipRecruiter

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

Industry

Medical equipment and supplies manufacturing

Company size

10,000+ Employees

Headquarters location

Irvine, CA, US

Year founded

1958

View All Edwards Lifesciences Jobs

Apply