Senior Regulatory Affairs Specialist
Advanced BioHealing Inc.
About Us We are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions. Our mission is to advance healing and recovery beyond expectations. What You Will Achieve: In this role, you will be primarily responsible for handling regulatory affairs requirements for medical devices and biologic products, including Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). You will develop regulatory strategies and regulatory submissions for new and modified commercial or investigational products to the FDA and International regulatory bodies. This individual will also provide regulatory support and guidance for post-marketing activities and product changes to US marketed products. This position reports to the Director of Regulatory Affairs. How You Will Achieve It: Working closely with Research & Development, Process Development, Manufacturing, and Quality departments to support the preparation of domestic and international regulatory submissions. This includes writing, reviewing, and editing regulatory documentation and technical reports, as well as formulating and executing regulatory decisions/actions. Lead and/or present during working meetings, including performing follow up activities to collaborate on regulatory submissions and activities that require input from cross functional stakeholders. Lead department strategic initiatives and training, including but not limited to assisting with onboarding/training of new hires and internal process improvements. Providing input on and review of protocols and reports including but not limited to process validation, equipment qualification, and shelf-life studies. Ensuring regulatory compliance with QSR/ISO 13485, cGCP, and cGMP requirements and stay apprised of ICH, FDA, and EU requirements. Evaluating changes to determine the filing requirements and impact on product regulatory status, AATB certifications, State licenses, and FDA registrations by authoring regulatory assessments. Review of labeling changes, and advertising and promotional material. Review of complaints to complete regulatory reporting determinations and regulatory filings for medical devices and biologic products. Review of biologic deviations to complete regulatory reporting determinations and regulatory filings for biologic products.
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