Globus Medical · 12 hours ago
Manager, Regulatory Affairs
King of Prussia, PA
Full-time
Onsite
Mid, Senior Level, Lead/Staff
8+ years expGlobus Medical is dedicated to delivering innovations that enhance the quality of life for patients with musculoskeletal disorders. The Manager, Regulatory Affairs, is responsible for preparing and filing submissions to the FDA, ensuring compliance with regulations, and managing the regulatory team to achieve timely approvals for medical devices.
Health CareManufacturingMedicalMedical DeviceWellness
Responsibilities
Guides the US Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations, responds to questions, and achieves timely regulatory clearance/approval for marketing
Develops Regulatory team expertise in project management, writing, testing methods, and product knowledge, and maintains staffing needs to support all current and near term US filings
Creates optimized regulatory strategies for 510(k) submissions, protocol development and study design, IDE / PMA submissions, and reports, to ensure most efficient approval times and most favorable labeling in terms of indications and reimbursement
Works with Product Development, Clinical Affairs, Quality, Management and other areas of the organization to obtain relevant information and subsequent review of submission content as needed
Reviews and approves Document Change Orders for US Regulatory, including Regulatory Pathway Form (RPF) determinations for all new and revised products, under departmental guidelines
Reviews and files Note-to-File documentation with engineering rationales for qualifying changes to 510(k) cleared products or systems and line extensions
Assists in review of product labeling and marketing materials
Provides regulatory oversight of changes in manufacturing facilities, processes, and procedures for PMA products
Assists in development of relevant regulatory SOPs and training staff as necessary
Ensures conformance to 21 CFR regulations
Assists with other regulatory matters as requested
Attends FDA meetings as requested
Understands relevant surgical techniques and clinical use of implant/instrument systems
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
BS degree in engineering or science-related field, or equivalent
Minimum of 8 years' experience in the medical device industry, or equivalent
Minimum of 3 years' experience in a regulatory capacity within the medical device industry, or equivalent, preferably with orthopedic or spinal devices
Demonstrated experience in obtaining 510(k) clearance
Demonstrated experience with IDE and PMA approval, preferably including panel-track PMA
Excellent verbal, written and organizational skills
Must be detail oriented
Preferred
Master's degree preferred
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