Regulatory Jobs
Hero Gradient Background
Globus Medical logo

New · posted Oct 15

Globus Medical · Medical Devices

Regulatory Associate

  • Audubon, PA
  • On-site
  • Full-time
  • Associate & Specialist
Save
PayNot published
EmploymentFull-time
LocationAudubon, PAOn-site
LevelAssociate & Specialist
FunctionRegulatory AffairsRegulatory
Deadline

Open until filled

The role

The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requiring working knowledge of products under review and of relevant regulations and guidance documents. This individual must be enthusiastic, positive, even-tempered and effective in building working relationships with internal teams while following FDA 21 CFR regulations.

At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.

What you need

  • Bachelor’s degree in health or science-related field, or equivalent; Engineering degree is a plus

  • Knowledge of US Code of Federal Regulations Title 21

  • Minimum of 0-2 years’ experience in medical device industry or equivalent, preferably within   orthopedic medical devices; Regulatory Affairs experience is a plus.

  • Excellent communication and listening skills

  • Proficient with Microsoft Office, including Word, Excel, PowerPoint and Teams

  • Strong time management skills, with the ability to work on multiple projects simultaneously

  • Able to work independently as well as within a team

Skills named in this posting

What you'll do

  1. Partnering with Product Development and management to prepare and review 510(k) submissions

  2. Preparing final 510(k) submissions and obtaining required management approvals

  3. Submitting 510(k) documents and responding to the FDA in a timely manner

  4. Assisting in the completion of IDE submissions for IDE clinical trials

  5. Helping to prepare PMA packages, including non-clinical, manufacturing, and clinical sections

  6. Working with personnel in various functional areas to obtain timely submissions to FDA

  7. Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting

  8. Reviewing Document Change Orders for Regulatory compliance, including drawings and labeling changes

  9. Performing routine maintenance of approved PMAs, including coordination and preparation of PMA supplements, Annual Reports

  10. Assisting in Regulatory Pathway Form determinations under departmental guidelines

  11. Administrative tasks, such as filing, scanning, organizing file, as needed. Reviewing and filing Note-to-File documentation for minor changes to 510(k) cleared products or systems

  12. Understanding the company’s products, surgical techniques and the use of implant and instrument systems

  13. Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies

  14. Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role

  15. Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus

Where you'll work

Audubon, PAOn-siteOpen in Maps (opens in a new tab)

More jobs in Audubon, PA

Working conditions

The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • Required to sit; climb or balance; and stoop, kneel, crouch or crawl

  • Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds

  • Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception

From the posting

About Globus Medical

Our Values

Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.

  • Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.

  • Customer Focused: We listen to our customers’ needs and respond with a sense of urgency.

  • Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.

  • Driven: We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.

Globus Medical company page · 11 open roles
Equal opportunity, accessibility and legal noticesGlobus Medical's statements, word for word

Equal Employment Opportunity

Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. 

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Job intelligence

The context around this role

Live data · October 15, 2026

Salary intelligence

How the pay compares

Associate & Specialist roles in the US27 roles publishing pay

Middle half $75,500 to $95,250, median $90,000
Annual base pay
Annual base payLowMedianHigh
All US$75,500$90,000$95,250

Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Regulatory Affairs

The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Globus Medical's own promotion track.

  1. This role

    Associate & Specialist

    Often: Regulatory Affairs Specialist · Summer 2027 Internship

    $90K median34 open

  2. Next step

    Senior & Principal

    Often: Senior Regulatory Affairs Specialist · Principal Regulatory Affairs Specialist

    $138K median69 open

  3. Later

    Manager

    Often: Regulatory Affairs Manager · Manager, Regulatory Affairs

    $163K median59 open

  4. Later

    Director

    Often: Director, Regulatory Affairs · Senior Director, Regulatory Affairs

    $235K median110 open

  5. Later

    VP & Executive

    Often: Vice President, Regulatory Affairs · Global Head of Injectable Aesthetics Regulatory Strategy

    $321K median18 open

Career resources on Regulatory Affairs

Skills DNA

What this role leans on

How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 4 linesLab testing and methods: 1 lineDocumentation and SOPs: 5 linesRegulatory submissions: 11 linesQuality systems and risk: 1 lineData and digital systems: 1 lineCollaboration and leadership: 6 linesGMPLab testingDocumentationSubmissionsQuality systemsData systemsTeamwork
  • Regulatory submissions11
  • Collaboration and leadership6
  • Documentation and SOPs5
  • GMP and compliance4
  • Lab testing and methods1
  • Quality systems and risk1
  • Data and digital systems1

Regulatory intelligence

The rules behind this role

Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.

From Regulatory News

Manufacturing and quality coverage for this profession

Company hiring pulse

Globus Medical on Regulatory Jobs

11
Open roles
10
Distinct roles
4
Locations

By discipline

  • Quality7 64%
  • Regulatory4 36%

By level

  • Associate & Specialist9 82%
  • Director1 9%
  • Senior & Principal1 9%
See all 11 Globus Medical roles

More roles at Globus Medical

All 11 Globus Medical roles

Similar Regulatory Affairs roles elsewhere

Regulatory Associate at Globus Medical

Open until filled.

Job alerts
    Regulatory Associate at Globus Medical — Audubon, PA | Regulatory Jobs