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Regulatory Operations Jobs in Delaware (NOW HIRING)

Hologic

Sr Manager, Regulatory Operations

Newark, DE · On-site

The Senior Manager, Regulatory Operations provides strategic and operational leadership to ensure compliant, efficient and scalable regulatory processes. This role is responsible for key regulatory ...

Vistra Nuclear Operations Company

Ensures technical excellence, regulatory compliance, and successful integration of all systems into existing plant infrastructure. Key Accountabilities * Provide Operations oversight and technical ...

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How much do regulatory operations jobs pay per hour?

As of Sep 14, 2026, the average hourly pay for regulatory operations in Delaware is $26.27, according to ZipRecruiter salary data. Most workers in this role earn between $17.79 and $30.34 per hour, depending on experience, location, and employer.

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.

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.

What are the key skills and qualifications needed to thrive in regulatory operations, 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.

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For Regulatory Operations jobs in Delaware, the most frequently searched job titles are:

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Regulatory Operations jobs near you
Infographic showing various Regulatory Operations job openings in Delaware as of August 2026, with employment types broken down into 86% Full Time, 13% Part Time, and 1% Contract. Highlights an 93% Physical, 3% Hybrid, and 4% Remote job distribution, with an average salary of $54,635 per year, or $26.3 per hour.

Sr Manager, Regulatory Operations

Newark, DE • On-site

Hologic
Health Care and Social Assistance • 5 - 10K employees
Learn more about Hologicexternal

Full-time

Posted 21 days ago

Hologic rating

8.0

Company rating: 8.0 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

Job description


Job Summary:
The Senior Manager, Regulatory Operations provides strategic and operational leadership to ensure compliant, efficient and scalable regulatory processes. This role is responsible for key regulatory operational areas including labeling, post-market regulatory reporting, state licensing and regulatory agency account maintenance, and Unique Device Identification (UDI) governance. This role ensures global compliance with regulatory requirements while enabling efficient, scalable processes that support a growing medical device portfolio. Provides counsel to and manages the regulatory team. Provides expertise in translating regulatory requirements into practical, workable plans. Interacts with regulatory agencies. Selects, develops, and evaluates personnel to ensure the efficient operation of the function.
Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives. Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.
Establishes operational objectives and work plans, and delegates assignments to subordinate managers. Senior management reviews objectives to determine success of operation. Involved in developing, modifying and executing company policies that affect immediate operations and may also have company-wide effect. Manages activities of two or more sections of departments. Exercises supervision in terms of costs, methods, and staffing. In some instances, this manager may have subordinate supervisors.
Essential Duties and Responsibilities:
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
  • Serve as the Divisional labeling process owner and ensure compliance with global labeling requirements (FDA, EU, and other international regulations). Oversee end-to-end labeling processes, including development, review, approval, and lifecycle management of product labeling.
  • Establish and maintain labeling procedures, systems, and controls to ensure accuracy, consistency, and traceability and manage external vendors for translations. Partner with Quality and Commercial teams to support timely product launches, updates, and changes.
  • Lead regulatory post-market summary reporting activities including managing timely submission of reports to regulatory authorities (i.e., Periodic Safety Update Report, Health Canada summary report)
  • Manage regulatory establishment registrations and device listings, oversee US state licensing requirements and maintain regulatory data integrity within external databases including FURLS and Eudamed.
  • Serve as process owner for UDI compliance and governance across global markets. Oversee UDI data creation, validation, and submission to regulatory databases (e.g., GUDID, Eudamed).
  • Leads global standards management process and drives cross-functional collaboration with R&D, Quality, Clinical, and Manufacturing teams to identify, assess, and implement applicable international and regional medical device standards (e.g., ISO, IEC, FDA-recognized); ensures effective communication of requirements, alignment on compliance strategies, and integration of standards into product development and lifecycle processes
  • Develop, implement and maintain procedures and processes for regulatory operations
  • Responsible for planning, assigning, and directing work, performance management, facilitating employee development, mentoring and coaching to maximize engagement and productivity. Directs activities as well as sets goals and objectives for the Regulatory function.
  • Updates job knowledge by studying trends and developments in Regulatory and Quality.

Qualifications:
Education
  • Preferred Minimum Non-Technical Degree: BA/BS Degree
  • Preferred Minimum Technical/Advanced Degree: Master's Degree

Experience
  • Preferred Minimum Non-Technical Degree: 10+ Years
  • Preferred Minimum Technical/Advanced Degree: 7+ Years with Master's Degree, 5+ Years with PhD

Skills
  • Excellent working knowledge of FDA Code of Federal Regulations (21CFR), ISO 13485, EU MDD/MDR regulations and relevant global regulations related to medical devices.
  • Strong knowledge in medical device labeling requirements and previous experience leading a labeling function preferred
  • Computer literate; able to use word processing, spreadsheet programs, databases.
  • Excellent ability to read, analyze and interpret professional journals, technical procedures, and government regulations.
  • Strong ability to effectively present information and respond to questions from senior management, function heads, managers, supervisors, and all levels of employees.
  • Excellent interpersonal skills to interact with all levels of the company, sometimes in an adversary role.
  • Demonstrated success in management role.
  • Ability to work effectively in a strongly matrixed team-oriented structure.
  • Excellent communication, interpersonal and relationship management skills
  • Experience in medical device, pharmaceutical or equivalent regulated industry
  • QA and/or RA certification is beneficial.

Ready to make a difference in women's health? Apply today and join our team of passionate innovators at Hologic!
Additional Info:
The annualized base salary range for this role is $145,000 to $241,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms, or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
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