Clinical Regulatory Specialist

Actalent; Eagleville (PA); On-site; USD 80,000 - 85,000; Full time

Benefits offered by this job

401(k) match

Paid time off

Full benefits package

On-site work

Job summary

Actalent in Audubon, PA is seeking a Clinical Regulatory Specialist to support U.S. regulatory filings for Class II/III devices.

The role partners with Product Development and Clinical Affairs to prepare 510(k) submissions, IDE/PMA packages, and post-approval maintenance. Candidates should have 2–5 years in regulatory affairs for medical devices, with direct 510(k) experience and familiarity with IDE/PMA processes.

Qualifications

• 2–5 years of Regulatory Affairs experience in medical devices.
• Direct experience supporting U.S. regulatory submissions (510(k), FDA Pre-Submissions).
• Familiarity with IDE and PMA submissions and post-approval activities.
• Experience reviewing labeling and controlled documentation for regulatory compliance.
• Strong written and verbal communication with attention to detail.

Responsibilities

• Prepare, review, and submit U.S. regulatory filings with emphasis on 510(k) submissions.
• Collaborate with Product Development, Clinical Affairs, and internal teams for submission content.
• Draft and assemble PMA/IDE sections and respond to FDA inquiries.
• Maintain PMAs, supplements, and post-approval reports with proper documentation.
• Evaluate regulatory impact of product changes and ensure regulatory pathways compliance.
• Train and mentor teammates on regulatory processes and SOPs.

Skills

Regulatory affairs

510(k) submissions

FDA interactions

PMA/IDE submissions

Documentation management

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree in health/science/engineering

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Microsoft Teams

Job description

Job Title: Clinical Regulatory Specialist

Job Description

The Clinical Regulatory Specialist supports the development, preparation, and submission of U.S. regulatory filings for Class II and Class III medical devices. This role partners closely with Product Development, Clinical Affairs, and other internal teams to prepare and review 510(k) submissions, coordinate supporting documentation, obtain final approvals, and respond to FDA requests. The Specialist assists with IDE and PMA submissions, contributes to nonclinical, manufacturing, and clinical sections of PMA packages, reviews clinical study data for regulatory reporting, and supports the ongoing maintenance of approved PMAs.

Responsibilities

• Support the preparation, review, and submission of U.S. medical device regulatory filings, with a focus on 510(k) submissions and FDA Pre-Submissions.
• Partner with Product Development, Clinical Affairs, and other internal teams to gather information, prepare submission content, and coordinate supporting documentation.
• Prepare final regulatory submission packages and assist in responding to FDA questions and requests for additional information.
• Assist with IDE and PMA submissions, including drafting and assembling nonclinical, manufacturing, and clinical sections of PMA packages.
• Review clinical study data, manufacturing information, and nonclinical documentation as needed to support regulatory reporting and submissions.
• Support the ongoing maintenance of approved PMAs, including PMA supplements, annual reports, and other post-approval activities.
• Evaluate the regulatory impact of product, manufacturing, design, and process changes, applying sound regulatory judgment and departmental guidelines.
• Review Document Change Orders, drawings, labeling changes, Regulatory Pathway Forms, and supporting documentation to determine appropriate regulatory pathways.
• Review labeling, promotional materials, and other controlled product documentation to ensure regulatory compliance and alignment with FDA requirements.
• Review and maintain Note-to-File documentation and other records to ensure documentation is accurate, complete, and compliant.
• Contribute to the development and refinement of Regulatory Standard Operating Procedures (SOPs) as needed.
• Collaborate cross-functionally with Product Development, Clinical Affairs, management, and other internal groups to obtain information required for submissions.
• Manage multiple projects and priorities simultaneously, using strong organization and time-management skills to meet deadlines.
• Document regulatory decisions clearly and maintain high standards of attention to detail and document management.
• Participate in training and knowledge-sharing activities, and when applicable, help train new team members on Regulatory processes.

Essential Skills

• Approximately 2 to 5 years of Regulatory Affairs experience in the medical device industry.
• Direct experience supporting U.S. medical device submissions, particularly 510(k)s and FDA Pre-Submissions.
• Experience with medical device development and product registration.
• Knowledge of U.S. medical device submission requirements, including 510(k) processes and FDA interactions.
• Experience evaluating the regulatory impact of product, manufacturing, design, or process changes.
• Experience reviewing labeling, promotional materials, and other controlled product documentation for regulatory compliance.
• Ability to review clinical, manufacturing, and nonclinical information for regulatory submissions.
• Familiarity with FDA regulations, applicable guidance documents, and Title 21 of the Code of Federal Regulations.
• Ability to understand technical products, product changes, and supporting documentation.
• Strong written and verbal communication skills.
• Excellent attention to detail and document-management skills.
• Ability to work independently while contributing effectively within a cross-functional team.
• Strong time-management skills with the ability to manage multiple projects and changing priorities.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Teams.
• Positive, professional, and responsive approach, with the ability to build productive working relationships.

Additional Skills & Qualifications

• Bachelors degree in a health, science, engineering, or related technical field; an engineering degree is preferred.
• Experience with Class II or Class III medical devices is preferred but not required.
• Orthopedic medical device experience is preferred but not required.
• Working knowledge of IDE and PMA submissions is a plus.
• Experience supporting PMA supplements, annual reports, or other post-approval maintenance activities is beneficial.
• Experience reviewing Document Change Orders, drawings, labeling changes, and similar controlled documentation.
• Experience training new team members on Regulatory processes is helpful but not required.
• Interest in building a long-term career in medical device Regulatory Affairs and learning from experienced Regulatory professionals.

Work Environment

This is a full-time, on-site position based at headquarters in Audubon, PA, with work performed on-site five days per week. The role involves close collaboration with Product Development, Clinical Affairs, and other technical teams in a professional office environment. Employees use standard business technology and software tools, including Microsoft Word, Excel, PowerPoint, and Teams, to prepare and manage regulatory documentation. The work setting emphasizes cross-functional teamwork, clear communication, and responsiveness, offering meaningful professional development and exposure to complex medical devices and regulatory processes.

Job Type & Location

This is a Permanent position based out of Eagleville, PA.

Pay And Benefits

The pay range for this position is $80000.00 - $85000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Full benefits package, 401(k) with a 4% company match, 22 total PTO days at the start: o 15 vacation days o 5 sick days o 2 personal days o 9 paid holidays

Workplace Type

This is a fully onsite position in Eagleville,PA.

Application Deadline

This position is anticipated to close on Oct 21, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.