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Entry Level Regulatory Affairs Associate Jobs (NOW HIRING)

CYNET SYSTEMS

Regulatory Affairs Associate

Sylmar, CA · On-site

$40 - $45/hr

Bachelor's degree in a scientific or related discipline. * 1+ years of direct regulatory experience in the medical device field. * Recent experience with Class III implantable medical devices is ...

New

Buckeye Global

Regulatory Affairs Associate I

Clark, NJ · On-site

$24 - $26/hr

Regulatory Coordinator ** **Applicable Shift: Onsite 100% during about 2 months training period; after that, potential for hybrid (3 days onsite, 2 days remote) - training period is subject to change ...

Buckeye Global

Regulatory Affairs Associate I

Clark, NJ · Hybrid

$24 - $26/hr

Regulatory Coordinator ** **Applicable Shift: Onsite 100% during about 2 months training period; after that, potential for hybrid (3 days onsite, 2 days remote) - training period is subject to change ...

5TH HQ LLC

Regulatory Affairs

Fort Lauderdale, FL · On-site

$19 - $20/hr

We are currently seeking a detail-oriented and motivated Regulatory Affairs Specialist. This role is crucial in ensuring that our products comply with all regulatory requirements. If you are ...

TeamSoft

$22 - $25/hr

Food Science Admin (Regulatory Affairs) Opening Location: East Hanover, NJ. Onsite M-F. Ongoing ... Zing's dedication to the safety, health & well-being of our associates, clients and communities ...

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Entry Level Regulatory Affairs Associate information

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$62

How much do entry level regulatory affairs associate jobs pay per hour?

As of Jul 17, 2026, the average hourly pay for entry level regulatory affairs associate in the United States is $39.57, according to ZipRecruiter salary data. Most workers in this role earn between $31.73 and $46.88 per hour, depending on experience, location, and employer.

What are some common challenges faced by Entry Level Regulatory Affairs Associates when adapting to regulatory changes?

Entry Level Regulatory Affairs Associates often encounter the challenge of staying up to date with frequent changes in local and international regulations. Adapting quickly requires strong research skills and attention to detail, as new guidelines can impact submission processes or product compliance. Collaborating closely with cross-functional teams, such as quality assurance and product development, is essential to ensure that all documentation aligns with the latest requirements. Proactively seeking mentorship and participating in training sessions can help new associates navigate these shifts more efficiently.

What does an Entry Level Regulatory Affairs Associate do?

An Entry Level Regulatory Affairs Associate supports the regulatory affairs team by helping to ensure that products comply with all relevant regulations and standards. This often includes preparing and submitting documentation to regulatory agencies, assisting with product registrations, and maintaining records. They also help to monitor changes in regulations and communicate important updates to internal teams. This role is essential for companies in industries like pharmaceuticals, medical devices, and biotechnology to bring products to market legally and efficiently.

What are the key skills and qualifications needed to thrive as an Entry Level Regulatory Affairs Associate, and why are they important?

To thrive as an Entry Level Regulatory Affairs Associate, you need a background in life sciences or related fields, strong attention to detail, and knowledge of regulatory guidelines and documentation. Familiarity with regulatory submission systems, document management tools, and sometimes certifications like RAC (Regulatory Affairs Certification) can be beneficial. Strong organizational skills, clear written and verbal communication, and the ability to work collaboratively make candidates stand out. These skills and qualifications are essential for ensuring compliance, timely submissions, and effective coordination in the highly regulated healthcare or pharmaceutical industries.

What is the difference between Entry Level Regulatory Affairs Associate vs Regulatory Affairs Specialist?

AspectEntry Level Regulatory Affairs AssociateRegulatory Affairs Specialist
QualificationsBachelor's degree in life sciences or related field; some certifications optionalBachelor's or master's degree; certifications like RAC beneficial
Work EnvironmentEntry-level, supporting regulatory documentation and researchMore independent, managing submissions and compliance strategies
Industry UsageCommonly used for early-career roles in pharma, biotech, medical devicesUsed for mid-level roles with increased responsibilities

Entry Level Regulatory Affairs Associates typically handle foundational tasks like document preparation and research, requiring basic industry knowledge. Regulatory Affairs Specialists have more experience, managing submissions and compliance strategies. Both roles are essential in regulated industries like pharmaceuticals and medical devices, but the Specialist role involves greater responsibility and independence.

More about Entry Level Regulatory Affairs Associate jobs
What cities are hiring for Entry Level Regulatory Affairs Associate jobs? Cities with the most Entry Level Regulatory Affairs Associate job openings:
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Entry Level Regulatory Affairs Associate jobs near you
Infographic showing various Entry Level Regulatory Affairs Associate job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 76% Full Time, 20% Part Time, 1% Temporary, and 2% Contract. Highlights an 79% Physical, 2% Hybrid, and 19% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.

Regulatory Affairs Associate

EKF Diagnostics Inc

Boerne, TX • On-site

Full-time

Re-posted 10 days ago

Job description

Job Type
Full-time
Description
Ensures company and products are in compliance with applicable regulations and legislation. Assists in maintaining the appropriate establishment registrations as well as product registrations and/or licensing. Assist with the preparation, compilation, and review of regulatory submissions and related regulatory documents. Collaborate with manager, project teams, and functional area representatives to implement sound regulatory strategy.
Essential Functions, included but not limited to :
  • Assist in monitoring implementation of new regulatory / legal requirements (including environmental legislation) in the relevant countries.
  • Maintain list of external standards.
  • Assist Regulatory Affairs department in preparing and submitting regulatory submissions such as 510(k) notifications for the US market and other regulatory documents in support of specific country registrations requirements.
  • Work in partnership with other departments (i.e., engineering, quality, manufacturing, sales, marketing, etc.) as necessary to support regulatory submissions and regulatory compliance.
  • Provide assistance with product vigilance/medical device adverse event reporting activities to include Medical Device Reporting (MDR) for the United States, and adverse reporting to Canadian authorities, etc.
  • Assist in preparation and coordination of issuing Technical Bulletins or Advisories.
  • Create and/or review product information in relation to Instructions for Use (IFUs), labeling, and sales and marketing literature.
  • Create and/or revise Standard Operating Procedures, Work Instructions, etc. as directed.
  • Assist with Regulatory Inquiries (internally and externally).
  • Assist in preparation and maintenance of country specific technical documentation (US, EU, etc.).
  • Assign and maintain Unique Device Identifiers (UDI) and database.
  • Participate and assist in audits conducted by regulatory agencies, registrars, certifying bodies, and customers to include end-users, distributors, and other OEM customers, as applicable.
  • Verify product marketing authorization (by country) and support release of product in system for distribution/sale within the authorized country.
  • Support with the creation and/or completion of Safety Data Sheets (SDSs), Toxic Substances Control Act (TSCA), etc., upon request.
  • Support compliance with Environmental, Social and Governance (ESG) Requirements.
  • Adhere to current Good Manufacturing Practices (cGMP).
  • Comply with Company policies, Quality Management System (QMS) and Standard Operation Procedure (SOPs), etc

Requirements
Required Qualifications:
  • High School Diploma or its equivalent.
  • Legally authorized to work in the United States.
  • Two (2) years proven quality and/or regulatory experience, within the medical device, In vitro diagnostics, biotechnology and/or pharmaceutical industries.
  • Knowledge of ISO 9001, ISO 13485, and the Quality System Regulation (21 CFR Part 820).

Preferred Qualifications:
  • Bachelor's degree (B.A./B.S.) from an accredited college or university in a science related field.
  • 4 years quality and/or regulatory experience in relation to medical device or In vitro diagnostics devices.
  • Knowledgeable with ERP systems such as ProAlpha, Oracle, SAP and AS400.
  • Experience with regulatory submissions to FDA, EU Notified Bodies, etc.
  • 1 year design and/or manufacturing experience.
  • Qualified Auditor experience.

Basic Skills and Abilities:
  • Detail oriented with a high level of accuracy, efficiency, and accountability.
  • Good computer skills including Microsoft Word, Excel, Outlook.
  • Excellent organizational skills to meet goals and set priorities.
  • Proven ability to handle multiple projects and meet deadlines; work in a fast-paced environment.
  • Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
  • Initiative to offer new innovative ideas and improve processes.
  • Ability to work independently and as a member of various teams and committees.
  • Project a positive company image by interacting with fellow employees, customers, and management in a cooperative, supportive, and courteous manner; displays a professional attitude.

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