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Regulatory Operations Jobs (NOW HIRING)

Underdog

Treasury Analyst, Regulatory Operations

OR · Remote

$100K - $120K/yr

Support and coordinate regulatory reporting, audits, examinations, and information requests related to treasury operations and customer protection requirements * Partner closely with Accounting ...

Emerald Resource Group

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Regulatory Coordinator

Cleveland, OH · On-site

$30/hr

The ideal candidate will have experience in trade compliance, import/export operations, regulatory documentation, or a related field. This individual should have strong attention to detail, excellent ...

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How much do regulatory operations jobs pay per hour?

As of Jul 22, 2026, the average hourly pay for regulatory operations in the United States is $26.24, according to ZipRecruiter salary data. Most workers in this role earn between $17.79 and $30.29 per hour, depending on experience, location, and employer.

What do regulatory operations do?

Regulatory operations professionals manage the processes and systems involved in preparing, submitting, and maintaining regulatory documents for product approvals and compliance. They ensure that regulatory submissions meet legal requirements, often using specialized software and adhering to strict deadlines. Their work supports the successful approval and ongoing compliance of products in regulated industries such as pharmaceuticals and medical devices.

What are common day-to-day responsibilities for professionals in Regulatory Operations?

Regulatory Operations professionals are primarily responsible for preparing, formatting, and submitting regulatory documents to health authorities, ensuring they meet stringent compliance standards. They coordinate with cross-functional teams—such as clinical, quality, and legal departments—to gather and verify required information. Daily tasks often include managing document workflows, maintaining regulatory databases, and tracking submission timelines. This role requires close attention to regulatory updates and an ability to quickly adapt processes in response to changing requirements.

How to get into regulatory operations?

To enter regulatory operations, candidates typically need a bachelor's degree in life sciences, healthcare, or a related field. Gaining experience with regulatory submissions, understanding compliance standards, and developing skills in document management and regulatory software can improve prospects. Certifications such as RAC (Regulatory Affairs Certification) can also enhance qualifications.

What are the key skills and qualifications needed to thrive in the Regulatory Operations position, and why are they important?

To excel in Regulatory Operations, candidates should have a strong understanding of regulatory guidelines, documentation processes, and compliance standards—often supported by a degree in life sciences, pharmacy, or a related field. Familiarity with electronic document management systems (EDMS), submission publishing tools, and possibly certifications such as Regulatory Affairs Certification (RAC) are commonly expected. Excellent attention to detail, project management, and effective communication skills enable individuals to coordinate across teams and ensure timely submissions. These competencies are critical for maintaining compliance, minimizing risk, and supporting the efficient approval of products in highly regulated industries.

What is the highest paying job in regulatory affairs?

The highest paying roles in regulatory affairs are typically senior executive positions such as Vice President or Director of Regulatory Affairs, which can offer salaries exceeding $150,000 annually. These roles often require extensive experience, leadership skills, and knowledge of regulatory compliance, often supported by advanced certifications like RAC (Regulatory Affairs Certification).

What is a Regulatory Operations job?

A Regulatory Operations job involves managing the submission and compliance processes required for regulatory approval of products, typically in industries like pharmaceuticals, biotechnology, and medical devices. Responsibilities include formatting and submitting regulatory documents, ensuring compliance with global regulations, and maintaining submission lifecycle management. This role often requires collaboration with cross-functional teams, expertise in regulatory guidelines, and proficiency in regulatory submission systems such as eCTD.

Is regulatory a good career?

Regulatory operations is a vital role in industries like pharmaceuticals, healthcare, and finance, ensuring compliance with laws and standards. It offers opportunities for career growth, requires attention to detail, and often involves working with regulatory agencies and documentation systems. The field can be stable and rewarding for those interested in legal and compliance processes.
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Regulatory Operations jobs near you
Infographic showing various Regulatory Operations job openings in the United States as of July 2026, with employment types broken down into 88% Full Time, 10% Part Time, 1% Temporary, and 1% Contract. Highlights an 95% Physical, 2% Hybrid, and 3% Remote job distribution, with an average salary of $54,588 per year, or $26.2 per hour.

Director, Regulatory Affairs Operations

TCV Administration

Ann Arbor, MI • On-site

$156K - $199K/yr

Full-time

Posted yesterday

Job description

At Terumo Cardiovascular, we develop, manufacture and distribute medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass, intra-operative monitoring and vascular grafting. This includes a full-line of perfusion products, endoscopic vessel harvesting products and surgical stabilization products. Our mission is to work as a team to save one more life, today and every day. We do this by providing lifesaving technology to cardiac surgery teams around the world.

At Terumo we’re working to build a healthier, happier society for our associates and the world. Our story begins over 100 years ago in Japan. Since then, we’ve been united by our mission to contribute to society through healthcare. As an associate at Terumo, your work helps to shape our evolution for the future. Working as one team, learning, innovating and challenging ourselves to write the future of healthcare. And no matter the location, no matter the team, we look out for one another, respect and support each other, strengthening trust with patients and healthcare providers everywhere.

Job Summary

This position is responsible for leading the development and optimization of regulatory operations, including regulatory processes, systems, submission planning, resource planning, regulatory intelligence, and metrics used to support global market access and ongoing compliance. Maintains current knowledge of global medical device regulations, acts as consultant to other departments, leads decision-making concerning policies, and participates in regulatory strategy. Defines information and actions needed to meet requirements, leads regulatory submissions required to obtain clearance or approval from governmental agencies. Interfaces with global regulatory affiliates and cross-functional partners to align regulatory deliverables, documentation, timelines, and implementation plans needed to achieve and maintain market access in global regions. Maintains compliance standing with regulatory and certifying agencies.

Job Details/Responsibilities

1.    In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. 
2.    Provide expertise to global regulatory strategy development and implementation to achieve completed regulatory submissions in a timely and fiscally responsible manner.
3.    Establish and execute submission schedule(s) and achieve plan commitments. Assure tactical objectives are achieved in U.S. and non-U.S. submissions, label and advertising review, removals and corrections support as well as recommend and implement procedural improvements.
4.    Assure compliance requirements are achieved. Interface with U.S. and non-U.S. government officials on compliance issues that assures credibility bringing issues to successful resolution.
5.    Manage timely global regulatory clearances for new products; maintain existing marketing authorizations.
6.    Accountable for U.S. and non-U.S. submissions including but not limited to IDE, 510(k), technical files, establishment registration, and device listing.
7.    Lead and continuously improve global regulatory operations processes, tools, templates, submission planning practices, and documentation standards to support consistent execution across regions.
8.    Develop, monitor, and report regulatory operations metrics, including submission timelines, approval status, market access milestones, and compliance deliverables.
9.    Partners with Regulatory Affairs, Quality, Clinical, Product Development, Marketing, and global affiliates to align regulatory deliverables with business priorities and project timelines.
10.    Provide leadership for regulatory intelligence, impact assessments, and implementation planning related to changing global regulatory requirements.
11.    Oversee maintenance of regulatory documentation, historical records, submission files, and regulatory databases in accordance with applicable requirements and internal procedures.
12.    Utilizes the systems and processes in place to attract, develop, engage, train, and retain talented Associates; creating a work environment where Associates can realize their full potential, thus allowing the organization to meet business needs.
13.    Perform other duties as assigned.

Qualifications/ Background Experiences

Requires a four-year college degree and a minimum of twelve years of experience in Regulatory Affairs and/or Quality for medical devices or pharmaceuticals, including one or more of the following: clinical studies, global marketing applications, regulatory operations, or quality systems management. Of the twelve years of experience a minimum of five years must include supervisory experience. Basic computer software skills, i.e., Microsoft Office. Advanced degree or additional professional training preferred.

The annualized base salary range for this role is $156,507.00 to $199,703.00. Final compensation packages will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand.

​Terumo Cardiovascular is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, sex, sexual orientation, gender identity and/or expression, and genetic information.

EOE Minorities/Women/Disabled/Veterans

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