New · posted Oct 15
Globus Medical · Medical Devices
Regulatory Affairs Specialist
- Audubon, PA
- On-site
- Full-time
- Associate & Specialist
Open until filled
The role
Performs a thorough regulatory assessment for proposed changes to current products and provides Regulatory support for line extensions and supplier change requests, ensuring compliance with local and regional registration requirements. Conducts an in-depth review of product literature and marketing collateral for all products, with an emphasis on Class II devices, to ensure Regulatory compliance. Monitors and improves tracking and control systems. Keeps abreast of regulatory procedures and changes.
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
Typically requires a minimum of 2 years of related experience with a Bachelor’s degree; or 1 year and a Master’s degree; or equivalent work experience
Two+ years of related experience in the medical device industry
Understanding of regulatory requirements throughout the product lifecycle
Solid understanding of regulatory terminology, pre-market submission types, and requirements
Able to evaluate regulatory impact of proposed product and process changes
Capable multi-tasking skills with the ability to project plan and meet deadlines
Result driven with a sense of responsibility, urgency and ability to perform under pressure
What you'll do
Performs a through regulatory assessment for proposed product changes, including supplier request changes and documents all related activates to remain in compliance
Demonstrates global regulatory expertise for change assessments with local regulations
Collaborates with various departments to review the required plans, procedures and regulatory decisions for existing products or line extensions
Conducts review of product literature and other marketing collateral (presentations, advertisements, social media posts, etc.) to ensure Regulatory compliance
Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry
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 this role
Represents the company in a professional manner and upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
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 visual 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 17 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance5
- Documentation and SOPs3
- Quality systems and risk3
- Collaboration and leadership3
- Regulatory submissions1
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%
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Regulatory Affairs Specialist at Globus Medical
Open until filled.