New · posted Oct 15
Globus Medical · Medical Devices
Regulatory Specialist
- Audubon, PA
- On-site
- Full-time
- Associate & Specialist
Open until filled
The role
The Regulatory Affairs Specialist assists with 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, requires 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
Minimum of 2-5 years’ experience in Regulatory Affairs in the medical device industry, , preferably within orthopedic medical devices;
Experience in medical device development and registration of products
Demonstrated knowledge of US regulatory submissions; Pre-Sub, and 510(k); working knowledge of IDE and PMA submissions a plus
Experience assessing regulatory impact of product/process changes
Experience reviewing labeling, promotional literature, etc.
Excellent communication and listening skills
Proficient with Microsoft Office, including Word, Excel, PowerPoint and Teams
Strong time management skills, demonstrated ability to work on multiple projects, priorities simultaneously
Able to work independently as well as within a team
What you'll do
Partners with Product Development and management to prepare and review 510(k) submissions
Prepares final 510(k) submissions and obtaining required management approvals
Submits 510(k) documents and responding to the FDA in a timely manner
Assists in the completion of IDE and PMA submissions for IDE clinical trials
Helps to prepare PMA packages, including non-clinical, manufacturing, and clinical sections
Works with personnel in various functional areas to obtain timely submissions to FDA
Obtains and reviews clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting
Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes
Performs routine maintenance of approved PMAs, including coordination and preparation of PMA supplements, Annual Reports
Trains new staff on relevant Regulatory processes as necessary
Determines Regulatory Pathway for new/changed products under departmental guidelines
Reviews and approve Regulatory Pathway Forms and supporting documentation
Reviews and approves Note-to-File documentation for minor changes to 510(k) cleared products or systems
Understands the company’s products, surgical techniques and the use of implant and instrument systems
Develops relevant Regulatory SOPs as necessary
Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
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
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, PAWorking 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 and capacity to adjust focus
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.
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
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $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.
Skills DNA
What this role leans on
How many of the posting's 30 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions13
- Documentation and SOPs7
- Collaboration and leadership6
- GMP and compliance3
- 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.
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification for medical devices
- FDAFDA PMA(official source, opens in a new tab)Premarket approval for class III medical devices
From Regulatory News
Manufacturing and quality coverage for this professionCompany 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%
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Regulatory Specialist at Globus Medical
Open until filled.