Position Summary:The Manager, Regulatory Affairs, is responsible for preparing, filing and gaining approval of 510(k), IDE, and PMA submissions to the U.S. Food and Drug Administration (FDA) for class II and class III products. This position entails management of submissions to the FDA, requiring 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 the FDA, surgeon investigators, researchers, and Globus personnel. This individual must adhere to FDA 21 CFR regulations in all duties. Experience should demonstrate dependability, flexibility and maturity. Individual must be able to travel up to 10% of the time.
Essential Functions:- 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.
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Qualifications:- BS degree in engineering or science-related field, or equivalent. Master's degree preferred.
- 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.
Physical Demands:The physical demands listed here are representative of those that must be met by and 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.
Other Duties: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.
