Clinical Regulatory Associate
The Clinical Regulatory Associate supports U.S. FDA regulatory submissions for Class II and Class III medical devices, contributing to 510(k), IDE, and PMA activities. This entry-level role involves preparing and organizing regulatory documentation, reviewing labeling and product changes, and collaborating with cross-functional teams to ensure compliance and accuracy. The position offers hands-on experience in medical device regulatory affairs within a fully on-site professional environment, ideal for early-career candidates seeking to build a long-term career in this field.
About Careertakes
👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Scientific & QA.
Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.
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 required for regulatory submissions; ensure completeness, accuracy, and version control.
- Prepare and format submission documents according to regulatory and quality procedures.
- Review product labeling and product-change documentation for regulatory consistency.
- Compile technical and clinical information to support regulatory pathway assessments and document regulatory strategies.
- Maintain regulatory files, track documentation, and archive submission materials.
- Apply foundational knowledge of FDA requirements, guidance documents, and 21 CFR while learning internal processes.
- Collaborate with senior Regulatory team members and cross-functional partners (Product Development, Clinical Affairs) to collect needed information.
- Communicate clearly with stakeholders, follow up on assigned items, and meet deadlines.
- Contribute to labeling reviews, design-control related documents, and quality documentation as needed.
- Participate in on-site interviews and ongoing feedback discussions; demonstrate receptiveness to coaching.
Essential Skills & Qualifications
- 0–2 years of relevant experience (Regulatory Affairs, clinical research, clinical trials, or related fields). Prior Regulatory experience preferred but not required.
- Bachelor’s degree in biomedical engineering, mechanical engineering, life/health sciences, or a related technical discipline. Engineering degree preferred.
- Demonstrated interest in Regulatory Affairs via coursework, internships, co-ops, academic projects, research, or related experience.
- Strong written and verbal communication skills for preparing submission materials and interacting with cross-functional teams.
- Excellent document review, organization, and version-control skills with meticulous attention to detail.
- Ability to manage multiple assignments concurrently and work independently while collaborating with senior staff.
- Familiarity or exposure to FDA regulations (21 CFR), 510(k), IDE, PMA, labeling, design controls, or quality documentation is beneficial.
- Proficiency with Microsoft Word, Excel, PowerPoint, and Teams.
- Positive, professional attitude and strong motivation to learn.
Work Environment
- This is a fully on-site position based in Trooper, PA. You will work closely with experienced Regulatory Affairs professionals in a professional office environment.
- On-site interview process may include multiple in-person conversations with the Regulatory team.
- Standard office technologies (Word, Excel, PowerPoint, Teams) are used for documentation and collaboration.
- Culture emphasizes professionalism, continuous learning, cross-functional teamwork, and receptiveness to feedback.
Compensation & Benefits
- Base pay range: $70,000 — $75,000 per year.
- Individual offers within the range depend on qualifications, experience, geographic location, and other job-related factors.
- Full benefits package, including 401(k) with a 4% company match.
- 22 total PTO days at hire:
- 15 vacation days
- 5 sick days
- 2 personal days
- 9 paid holidays.
Workplace Type
- Fully onsite in Trooper, PA.
Application Deadline
- This position is anticipated to close on Oct 21, 2026.
Equal Opportunity & Hiring Transparency
Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.
If you have questions about how your data is used, please contact us directly.
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