Hiring: Manager, Regulatory Affairs Company: Globus Medical Location: King of Prussia, PA Job Posted Time: 2026-09-12 12:29:19 Target Skills & Keywords : Project Management About the job Required Skills: •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. Qualifications: •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. Compensation: •Flexible work environment (work from home / hybrid options) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!