IntePros
Overview
Join to apply for the
Regulatory Affairs Manager
role at
IntePros . IntePros is currently looking for a
Regulatory Affairs Manager
to join one of our growing Medical Device clients in Audubon, PA. The
Regulatory Affairs Manager
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 adhere to FDA 21 CFR regulations in all duties. Travel up to 10-20% of the time may be required. Responsibilities
Guide the US Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations; respond to questions and achieve timely regulatory clearance/approval for marketing. Develop Regulatory team expertise in project management, writing, testing methods, and product knowledge; maintain staffing needs to support 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 efficient approval times and favorable labeling in terms of indications and reimbursement. 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 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 and attend FDA meetings as needed. Understand relevant surgical techniques and clinical use of implant/instrument systems. Adhere to the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensure compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, through training and ongoing knowledge of regulatory affairs as it applies to the role. Represent the company professionally and uphold ethical business practices in interactions with employees, customers, suppliers, and third parties. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Qualifications
Master’s degree in engineering or science-related field, or equivalent. Minimum of 8 years’ experience in the medical device industry, with at least 3 years in a regulatory capacity; orthopaedic or spinal devices experience is preferred. 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 and strong attention to detail. Referrals increase your chances of interviewing at IntePros. Sign in to set job alerts for “Regulatory Affairs Manager” roles.
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Join to apply for the
Regulatory Affairs Manager
role at
IntePros . IntePros is currently looking for a
Regulatory Affairs Manager
to join one of our growing Medical Device clients in Audubon, PA. The
Regulatory Affairs Manager
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 adhere to FDA 21 CFR regulations in all duties. Travel up to 10-20% of the time may be required. Responsibilities
Guide the US Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations; respond to questions and achieve timely regulatory clearance/approval for marketing. Develop Regulatory team expertise in project management, writing, testing methods, and product knowledge; maintain staffing needs to support 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 efficient approval times and favorable labeling in terms of indications and reimbursement. 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 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 and attend FDA meetings as needed. Understand relevant surgical techniques and clinical use of implant/instrument systems. Adhere to the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensure compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, through training and ongoing knowledge of regulatory affairs as it applies to the role. Represent the company professionally and uphold ethical business practices in interactions with employees, customers, suppliers, and third parties. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Qualifications
Master’s degree in engineering or science-related field, or equivalent. Minimum of 8 years’ experience in the medical device industry, with at least 3 years in a regulatory capacity; orthopaedic or spinal devices experience is preferred. 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 and strong attention to detail. Referrals increase your chances of interviewing at IntePros. Sign in to set job alerts for “Regulatory Affairs Manager” roles.
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