Globus Medical
Overview
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Manager, Regulatory Affairs
role at
Globus Medical . 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 Globus personnel. This individual must adhere to FDA 21 CFR regulations in all duties. Travel up to 10% may be required.
Responsibilities
Lead the US Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, and all international regulatory submissions and registrations; respond to questions and achieve timely regulatory clearance/approval for market entry.
Develop Regulatory team expertise in project management, writing, testing methods, and product knowledge; ensure staffing supports current and near-term US filings.
Create optimized regulatory strategies for 510(k) submissions, protocol development, study design, IDE/PMA submissions, and reports to improve approval times and labeling.
Collaborate with Product Development, Clinical Affairs, Quality, Management, and other areas to obtain information and review submission content as needed.
Review and approve Document Change Orders for US Regulatory, including Regulatory Pathway Form determinations for new and revised products.
Review and file Note-to-File documentation with engineering rationales for changes to 510(k) cleared products or systems and line extensions.
Assist in review of product labeling and marketing material.
Provide regulatory oversight of changes in manufacturing facilities, processes, and procedures for PMA products.
Assist in development of regulatory SOPs and train staff as necessary.
Ensure conformance to 21 CFR regulations.
Attend FDA meetings as requested and understand relevant surgical techniques and clinical use of implant/instrument systems.
Adhere to the company Code of Conduct, AdvaMed Code, MedTech Code, and applicable company policies.
Ensure compliance with applicable governmental laws, rules, and regulations, by completing training and maintaining knowledge relevant to the role.
Represent the company professionally and uphold ethical business practices in all interactions.
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.
Experience with IDE and PMA approvals, preferably including panel-track submissions.
Excellent verbal, written and organizational skills; attention to detail.
Position Summary The Group Manager, US Regulatory, is responsible for preparing, filing and gaining approval of 510(k), IDE, and PMA submissions to the U.S. 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 regulations and guidance documents. Travel up to 10% may be required.
Essential Functions
Guide the US Regulatory team in preparing and filing regulatory submissions, responding to questions, and achieving timely clearance/approval.
Develop and maintain staffing to support current and near-term US filings; foster team expertise in project management and regulatory writing.
Develop strategies for 510(k), IDE, and PMA submissions to optimize approval times and labeling.
Collaborate with cross-functional teams to obtain information and review submission content as needed.
Review regulatory changes and ensure compliance with related documentation and processes.
Review labeling and marketing materials for regulatory compliance.
Maintain knowledge of regulatory requirements and ensure ongoing compliance across the organization.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering, Manufacturing, and Product Management
Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr
Join to apply for the
Manager, Regulatory Affairs
role at
Globus Medical . 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 Globus personnel. This individual must adhere to FDA 21 CFR regulations in all duties. Travel up to 10% may be required.
Responsibilities
Lead the US Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, and all international regulatory submissions and registrations; respond to questions and achieve timely regulatory clearance/approval for market entry.
Develop Regulatory team expertise in project management, writing, testing methods, and product knowledge; ensure staffing supports current and near-term US filings.
Create optimized regulatory strategies for 510(k) submissions, protocol development, study design, IDE/PMA submissions, and reports to improve approval times and labeling.
Collaborate with Product Development, Clinical Affairs, Quality, Management, and other areas to obtain information and review submission content as needed.
Review and approve Document Change Orders for US Regulatory, including Regulatory Pathway Form determinations for new and revised products.
Review and file Note-to-File documentation with engineering rationales for changes to 510(k) cleared products or systems and line extensions.
Assist in review of product labeling and marketing material.
Provide regulatory oversight of changes in manufacturing facilities, processes, and procedures for PMA products.
Assist in development of regulatory SOPs and train staff as necessary.
Ensure conformance to 21 CFR regulations.
Attend FDA meetings as requested and understand relevant surgical techniques and clinical use of implant/instrument systems.
Adhere to the company Code of Conduct, AdvaMed Code, MedTech Code, and applicable company policies.
Ensure compliance with applicable governmental laws, rules, and regulations, by completing training and maintaining knowledge relevant to the role.
Represent the company professionally and uphold ethical business practices in all interactions.
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.
Experience with IDE and PMA approvals, preferably including panel-track submissions.
Excellent verbal, written and organizational skills; attention to detail.
Position Summary The Group Manager, US Regulatory, is responsible for preparing, filing and gaining approval of 510(k), IDE, and PMA submissions to the U.S. 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 regulations and guidance documents. Travel up to 10% may be required.
Essential Functions
Guide the US Regulatory team in preparing and filing regulatory submissions, responding to questions, and achieving timely clearance/approval.
Develop and maintain staffing to support current and near-term US filings; foster team expertise in project management and regulatory writing.
Develop strategies for 510(k), IDE, and PMA submissions to optimize approval times and labeling.
Collaborate with cross-functional teams to obtain information and review submission content as needed.
Review regulatory changes and ensure compliance with related documentation and processes.
Review labeling and marketing materials for regulatory compliance.
Maintain knowledge of regulatory requirements and ensure ongoing compliance across the organization.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering, Manufacturing, and Product Management
Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr