Globus Medical · 1 week ago
Sr Regulatory Affairs Specialist
King of Prussia, PA
Full-time
Onsite
Senior Level
5+ years expGlobus Medical is dedicated to improving the quality of life for patients with musculoskeletal disorders through innovative solutions. The Sr Regulatory Affairs Specialist will coordinate and prepare document packages for regulatory submissions, ensure compliance with registration requirements, and recommend strategies for clinical trial approvals.
Health CareManufacturingMedicalMedical DeviceWellness
Responsibilities
Determines the appropriate regulatory strategy for new products and documents all related activates to remain in compliance
Demonstrates global regulatory expertise in product submissions and evaluates changes with local regulations
Collaborates with various departments to review the required plans, procedures and regulatory decisions for new or existing products
Reviews regulatory requirements from other departments for new product designs or changes to existing designs
Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry
Prepares and maintains regulatory pre-market submissions and other pre-market filings to assist in acquiring appropriate commercial distribution clearances
Supports product import by providing applicable regulatory documentation and certificates
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
Qualification
Required
Typically requires a minimum of 5 years of related experience with a Bachelor's degree; or 3 years and a Master's degree; or a PhD without experience; or equivalent work experience
5+ 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
Company
Globus Medical
Globus Medical is a musculoskeletal implant manufacturer, driving technological advancements across a suite of spinal products.
1001-5000 employees
H1B Sponsorship
Globus Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (24)
2024 (17)
2023 (13)
2022 (8)
2021 (9)
2020 (11)
Funding
Current Stage
Public CompanyTotal Funding
$128.52MKey Investors
Clarus Ventures
2012-08-03IPO
2007-08-23Series E· $110M
2007-02-05Series D· $9.45M
Leadership Team
Norbert Johnson
CTO of Imaging, Navigation & Robotics
Harri Hallila
Managing Director, International Advanced Technologies
Recent News
2026-01-16
2026-01-08
2026-01-08
Company data provided by crunchbase