Clinical Regulatory Associate

Actalent; Eagleville (PA); On-site; USD 70,000 - 75,000; Full time

Benefits offered by this job

Full benefits package

401(k) with 4% company match

22 total PTO days

Job summary

Actalent in Audubon, PA, seeks a Clinical Regulatory Associate to support FDA submissions for Class II and III medical devices. You will learn from experienced professionals, gather documentation, and help prepare 510(k), IDE, and PMA materials while collaborating with cross-functional teams.

This on-site role emphasizes attention to detail, strong communication, and a growing foundation in regulatory affairs.

Qualifications

• Demonstrated interest in Regulatory Affairs through coursework, internships, projects, or early professional experience.
• 0–2 years of Regulatory Affairs, clinical research, or related experience; RA experience preferred but not required.
• Strong written communication for submission documents and labeling review.
• Strong verbal communication to interact with senior Regulatory team members and cross-functional partners.
• Excellent document review and organizational skills ensuring completeness and accuracy of technical documentation.
• Ability to follow established regulatory/documentation processes with attention to detail.
• Ability to manage multiple assignments concurrently and work with senior team members.
• Familiarity with FDA regulations or 21 CFR is preferred; exposure to 510(k), IDE, PMA is beneficial.
• Proficiency with Word, Excel, PowerPoint, and Teams.

Responsibilities

• Support portions of U.S. FDA submissions for Class II and Class III medical devices (510(k), IDE, PMA).
• Gather, organize, and maintain documentation for regulatory submissions; ensure accuracy and compliance.
• Assist with preparation and formatting of submission documents per procedures.
• Review labeling and change documentation for regulatory alignment.
• Contribute to regulatory pathway assessments and document regulatory strategies.
• Maintain regulatory files, version control, and archiving of submission materials.
• Learn FDA requirements and Title 21 CFR while integrating internal processes.
• Collaborate with Product Development, Clinical Affairs, and other partners for submission data.
• Communicate clearly with stakeholders and track assigned items to submission milestones.
• Organize information and manage multiple tasks with deadlines and quality focus.
• Follow documentation/review processes with attention to detail and accuracy.
• Contribute to labeling reviews, product-change docs, and design-control related records.
• Participate in on-site interviews and feedback discussions to learn continuously.

Skills

Regulatory Affairs interest

0–2 years experience

Written communication

Verbal communication

Detail-oriented

Document review

Independence with collaboration

Education

Biomedical/Mechanical/Health sciences degree

Engineering degree preferred

Tools

Microsoft Word, Excel, PowerPoint, Teams

Job description

Job Title: Clinical Regulatory Associate

Job Description

The Clinical Regulatory Associate joins the Premarket Regulatory Affairs team and supports U.S. regulatory submissions for Class II and Class III medical devices. In this entry-level role, you contribute to portions of FDA submissions, including 510(k), IDE, and PMA activities, while learning directly from experienced Regulatory Affairs professionals and collaborating with cross-functional teams. This position is ideal for recent graduates or early-career candidates who demonstrate strong academic performance, meticulous attention to detail, and a clear interest in building a long-term career in medical device Regulatory Affairs.

Responsibilities

• Support portions of U.S. FDA submissions for Class II and Class III medical devices, including 510(k), IDE, and PMA activities.
• Gather, organize, and maintain documentation required for regulatory submissions, ensuring materials are complete, accurate, and compliant with internal processes.
• Assist with the preparation and formatting of submission documents, following established regulatory and quality procedures.
• Review product labeling and product-change documentation to help ensure consistency with regulatory requirements and internal standards.
• Support regulatory pathway assessments by compiling relevant technical and clinical information and helping to document regulatory strategies.
• Maintain regulatory files and records, including tracking documentation, version control, and archiving submission materials.
• Apply foundational knowledge of FDA requirements, guidance documents, and Title 21 of the Code of Federal Regulations while learning internal regulatory processes.
• Collaborate with senior Regulatory team members, Product Development, Clinical Affairs, and other internal partners to gather information needed for submissions.
• Communicate clearly with cross-functional stakeholders, ask thoughtful questions, and follow up on assigned items to keep submission activities on track.
• Organize detailed information and manage multiple assignments simultaneously while meeting deadlines and quality expectations.
• Follow established documentation and review processes with close attention to detail and a strong focus on accuracy.
• Contribute to labeling reviews, product-change documentation, and quality or design-control related documentation as needed.
• Participate in on-site interviews and ongoing feedback discussions, demonstrating receptiveness to coaching and commitment to continuous learning.

Essential Skills

• Demonstrated interest in pursuing a career in Regulatory Affairs, shown through relevant coursework, internships, co-ops, academic projects, research, or early professional experience.
• Approximately 0 to 2 years of relevant experience in Regulatory Affairs, clinical research, clinical science, clinical trials, or clinical development; prior Regulatory Affairs experience is preferred but not required.
• Strong written communication skills for preparing submission documents, reviewing labeling, and handling product documentation.
• Strong verbal communication skills to interact effectively with senior Regulatory team members and cross-functional partners.
• Excellent document review and organizational skills, with the ability to verify completeness and accuracy of technical documentation.
• Ability to follow established regulatory and documentation processes with meticulous attention to detail.
• Ability to organize detailed information and work on multiple assignments simultaneously.
• Capability to work independently while also collaborating effectively with senior team members and cross-functional partners.
• Familiarity with FDA regulations or Title 21 of the Code of Federal Regulations (21 CFR) is preferred.
• Exposure to 510(k)s, IDEs, PMAs, labeling, design controls, document-change processes, or quality documentation is beneficial.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Teams.
• Positive, professional attitude, receptiveness to feedback, and strong motivation to learn.
• Comfort working fully on-site and participating in multi-part, in-person interview discussions.

Additional Skills & Qualifications

• Bachelors degree in biomedical engineering, mechanical engineering, health sciences, life sciences, or another relevant scientific or technical discipline.
• Engineering degree is preferred but not required.
• Strong academic performance is highly desired, including GPA, academic honors, Deans List recognition, and other notable academic achievements.
• Regulatory Affairs coursework, internships, co-ops, research, or other regulatory exposure is preferred.
• Experience as a Clinical Research Coordinator may be considered, particularly when accompanied by strong documentation skills and a demonstrated interest in Regulatory Affairs.
• Experience with clinical research, clinical science, clinical trials, or clinical development is beneficial.
• Experience working with labeling, design controls, document-change processes, or quality documentation is a plus.
• Ability to build effective working relationships across Product Development, Clinical Affairs, and other technical functions.
• Demonstrated time management skills and ability to support multiple projects in parallel.
• Interest in gaining hands-on exposure to complex medical devices and the full lifecycle of FDA submission activities.
• Desire to develop a strong foundation for advancement within medical device Regulatory Affairs.

Work Environment

This role is based fully on-site, five days per week, at a headquarters location in Audubon, PA. You work closely with experienced Regulatory Affairs professionals and collaborate with Product Development, Clinical Affairs, and other technical teams in a professional office environment. The position offers hands-on exposure to FDA submission activities for Class II and Class III medical devices, including 510(k), IDE, and PMA processes. Standard office technologies and tools are used, including Microsoft Word, Excel, PowerPoint, and Teams for documentation, communication, and collaboration. The culture emphasizes professionalism, continuous learning, cross-functional teamwork, and receptiveness to feedback. Candidates must be comfortable participating in an on-site interview consisting of four separate 30-minute conversations with members of the Regulatory team and adhering to typical professional office attire.

Job Type & Location

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

Pay and Benefits

• The pay range for this position is $70000.00 - $75000.00/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.