Regulatory Affairs Manager

In This Position, You Will Have the Opportunity To Market Clearance: Determine requirements and generate market clearance applications, as needed, for US and OUS which may include 510(k), STED Files, Design Dossiers and similar submissions for ROW (Rest of World). Support Global Expansion & in-country RA personnel for ROW global product registrations. Create and maintain product summary technical documentation (STED) to support global product registrations Support international registration activities required by our customers or international distributors Assess the acceptability of quality, preclinical and clinical documentation for submission filing Ensure annual Regulatory activities are completed (FDA Registration, Canadian Device Licenses, FURLS Listing, State Licenses) May serve as primary interface with the notified body including relationship management, audit scheduling, and related follow-up activities Manage ISO and CE certifications to ensure all required internationally sold devices are accurately depicted Review labeling, IFU’s, advertising, promotional items, sales and marketing literature to ensure all comply with related standards Provide Regulatory support for New Product Development which includes product classification review and regulatory submission requirements Responsible for supporting research, development, and sustaining engineering teams on required medical device performance and safety standards. Review scientific/engineering materials (protocols/reports), support continuous improvement activities and provide regulatory assessment on proposed changes to marketed devices Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of QA/RA and related teams Participate in Risk Management and Post Market Surveillance as part of a cross-functional team Monitor and submit applicable vigilance reports and ensures appropriate responses are submitted to regulatory authorities Responsible for keeping the product portfolio in compliance with worldwide standards and regulations by maintaining awareness of changing global regulatory requirements / technical publications and communicating the impact to internal teams to implement the required updates. Facilitates communication and tracking of changes to regulations and standards by creating, maintaining and updating a library of information. Support regulatory projects and OUS regulatory relations with Authorized Representatives and In Country Caretakers Review and approve customer and distribution QA/RA contracts to ensure conformance and accuracy of content Provide assistance in product notification and recall activities Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing strategies Manage product change control to ensure regulatory compliance is maintained throughout changes What You Need to Succeed in This Position Bachelor’s Degree or equivalent job experience; M.S. in a technical area or M.B.A. is preferred Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) is a plus 5+ year work experience in a regulated industry (e.g., medical devices, combination products) 5+ years’ experience in regulatory affairs and/or product development in medical devices Medical device, biological, or pharmaceutical environment preferred Note: Higher education may compensate for years of experience Must have knowledge of ethical guidelines of the regulatory profession, clinical research, and regulatory process Knowledge of regulatory history, guidelines, policies, standards, practices, requirements, and precedents; principles and requirements of applicable product laws Knowledge of International submission/registration types and requirements; domestic and international guidelines, policies, and regulations (GxPs (GCPs, GLPs, GMPs). Experience with principles and requirements of promotion, advertising, labeling, and EU Medical Device…