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Added 3 days ago
Controls Technician - Nights
Mars Petcare US, Inc.
United States
…state-of-the-art manufacturing plant in Fort Smith, AR! Being a Mars Associate is all about opportunity. The opportunity to do challenging, exciting work that shapes the world’s best-loved…
Added 3 days ago
Business Systems Analyst II (Electronic Pymt Ops)
UMB BANK NA
Kansas City, MO
You can expect a fast-paced environment with unpredictable scenarios while maintaining flexibility and adaptability to client needs. Our Business Systems Analyst II are motivated to be…
Added 3 days ago
OS
Universal Banker I, II, III - Darien, IL (Cass Ave)
Old Second National Bank
Darien, IL
- $18.1 to $29 USD / hour
Responsible for Operational Accuracy and Compliance (ex. Records, TD Ops, BSA/Fraud/CTR’s, BAI, Signature Cards, CIP, Beneficial Ownership).
Added 3 days ago
Recruitment Drive: Java / .Net / BA
Saviance Technologies
New York, NY
Added 9 days ago
Product Manager II (U.S. Air Force)
Skylight
United States
…Product managers partner with researchers, designers, engineers, client stakeholders, and others to inform their product decisions. At a high level, it’s the product manager’s job to figure…
Added 11 days ago
Senior/Staff/Principal Data Scientist (HHS)
Skylight
United States
…you’ll help shape them rather than execute against a fixed spec. Client leadership believes moving too slowly is a bigger risk than being wrong, so you’ll do well here if you like…
Added 11 days ago
MS
Client Onboarding Operations Associate
MS Services Group, Inc.
NY
- $65,000 to $103,000 USD / year
We’re seeking someone to join our team as an Associate in Client Onboarding Operations. The Client Onboarding team supports all product and functional areas directly and indirectly impacted…
Added 11 days ago
S
Alternative Ops Derivatives & Collateral Management, Associate 2
SSB&T
Quincy, MA
- $41,600 to $66,560 USD / year
…Derivatives Center of Excellence as a Derivative Swap Specialist, Associate II. The ideal candidate will be eager to learn, attentive to detail, and interested in building a career in…
Added 12 days ago
Staff Product Manager, Technical (HHS)
Skylight
United States
…Product managers partner with researchers, designers, engineers, client stakeholders, and others to inform product decisions. At a high level, it’s the product manager’s job to figure out…
Added 12 days ago
Staff Product Manager (HHS)
Skylight
United States
…Product managers partner with researchers, designers, engineers, client stakeholders, and others to inform their product decisions. At a high level, it’s the product manager’s job to figure…
Added 13 days ago
OS
Universal Banker I, II, III - Bolingbrook, IL (East Boughton Rd)
Old Second National Bank
Bolingbrook, IL
- $18.1 to $29 USD / hour
Responsible for Operational Accuracy and Compliance (ex. Records, TD Ops, BSA/Fraud/CTR’s, BAI, Signature Cards, CIP, Beneficial Ownership).
Added 16 days ago
Senior/Staff Product Manager, Technical (ACF)
Skylight
United States
…Product managers partner with researchers, designers, engineers, client stakeholders, and others to inform their product decisions. At a high level, it’s the product manager’s job to figure…
Added 16 days ago
Senior/Staff Data Scientist (ACF)
Skylight
United States
Experience working on cross-functional teams (product, design, engineering, ops) in iterative delivery
Added 16 days ago
Production Services Specialist II
Bank of America, National Association
United States
…expectations include serving as a key focal point for the customer, client, and associate experience and restoring any impacts to those experiences regardless of where the root cause of the…
Added 16 days ago
Coordinator of Programs and Events
University of Florida
Gainesville, FL
…and interpret relevant data for other team members, faculty, associate director and director. Create and/or update all other associated documents for this…
Added 17 days ago
A
Clinical Regulatory Associate
Actalent
Eagleville, PA
- $70,000 to $75,000 USD / year
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,…
Added 17 days ago
ER
Consulting Associate, Geologist
Environmental Resources Management, Inc.
Walnut Creek, CA
- $68,000 to $86,500 USD / year
Consulting Associate level: less than 1 year of relevant environmental experience, including internships, co-ops, or other related experience.
Added 23 days ago
Production Services Specialist II
Bank of America, National Association
United States
…and procedures, serving as a focal point for the customer, client, and associate experience, restoring complex production incidents under tight Service Level Agreements, and pursuing root…
Added 23 days ago
Production Services Specialist II
Bank of America, National Association
United States
…and procedures, serving as a focal point for the customer, client, and associate experience, restoring complex production incidents under tight Service Level Agreements, and pursuing root…
Added 24 days ago
Various High-Level IT Positions (PM, BA, Dev, Ops, DBA etc.) for TX Govt. Entity
Management Applications, Inc.
Amarillo, TX
Associate's degree and 3 plus years’ experience or equivalent
Added 24 days ago
Various High-Level IT Positions (PM, BA, Dev, Ops, DBA etc.) for TX Govt. Entity
Management Applications, Inc.
Fort Worth, TX
Associate's degree and 3 plus years’ experience or equivalent
Added 24 days ago
Various High-Level IT Positions (PM, BA, Dev, Ops, DBA etc.) for TX Govt. Entity
Management Applications, Inc.
San Antonio, TX
Associate's degree and 3 plus years’ experience or equivalent
Added 24 days ago
Various High-Level IT Positions (PM, BA, Dev, Ops, DBA etc.) for TX Govt. Entity
Management Applications, Inc.
Houston, TX
Associate's degree and 3 plus years’ experience or equivalent
Added 24 days ago
Various High-Level IT Positions (PM, BA, Dev, Ops, DBA etc.) for TX Govt. Entity
Management Applications, Inc.
Austin, TX
Associate's degree and 3 plus years’ experience or equivalent
Added 26 days ago
OS
Universal Banker I, II, III - North Aurora, IL
Old Second National Bank
North Aurora, IL
- $18.1 to $29 USD / hour
Responsible for Operational Accuracy and Compliance (ex. Records, TD Ops, BSA/Fraud/CTR’s, BAI, Signature Cards, CIP, Beneficial Ownership).

Actalent

Clinical Regulatory Associate

Eagleville, PA, United States

$70,000 to $75,000 USD / year

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Job details

Pay: $70,000 to $75,000 USD / year
Posting language: English
Posted: Oct 8, 2026

Original 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 actalentaccommodation@actalentservices.com 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.

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More about this job

Skills

Regulatory affairs
Medical devices
IDE
Attention to detail
Documentation
Coaching
Research
Clinical research
Clinical science
Clinical trials
Communication skills
Organizational skills
Work independently
Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Microsoft Teams
Biomedical engineering
Mechanical engineering
Time management
Collaboration
Teamwork

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