Job Location: Trooper, PA
GROUP MANAGER, REGULATORY AFFAIRS, U.S.
The Group Manager, US Regulatory, 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 company 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 10-20% of the time.
- Guide the US Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations, responding to questions, and achieving timely regulatory clearance/approval for marketing.
- Develop Regulatory team expertise in project management, writing, testing methods, and product knowledge, and maintain staffing needs to support all current and near term US filings.
- Create 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.
- Work 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.
- Review and approve Document Change Orders for US Regulatory, including Regulatory Pathway Form (RPF) determinations for all new and revised products, under departmental guidelines.
- Review and file Note-to-File documentation with engineering rationales for qualifying changes to 510(k) cleared products or systems and line extensions.
- Assist in review of product labeling and marketing materials.
- Provide regulatory oversight of changes in manufacturing facilities, processes, and procedures for PMA products.
- Assist in development of relevant regulatory SOPs and training staff as necessary
- Ensure conformance to 21 CFR regulations.
- Assist with other regulatory matters as requested.
- Attend FDA meetings as requested.
- Understand relevant surgical techniques and clinical use of implant/instrument systems.
- Masters 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 orthopaedic 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.
- Good computer skills.
- Must be detail-oriented.
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.
No visa sponsorship (H1-B, etc.) at this time, sorry.
How To Apply:
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