Job Description

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 strength is giving others strength. Learn more about Careers at Organogenesis What You Will Achieve: Assists the regulatory department in the generation, formatting, and preparation/publishing or review of regulatory submissions or non-submission documents (paper or electronic), for either internal customers or external clients, for Medical Devices, Human Cells, Tissues and Tissue-based products (HCT/Ps) and Biologics. Participates on project teams and may lead specific regulatory tasks, under the guidance of senior staff. How You Will Achieve It: Participant on product development teams responsible for providing guidance on regulatory issues and procedural recommendations for standard operating procedures and protocols Assist in the evaluation of change control documents for impact on submissions and filing requirements Review device labeling and advertising materials for compliance with approvals and applicable regulations; analyze and recommend appropriate changes Collaborate with quality assurance to manage, 21CFR compliance and design control programs and other regulatory bodies Ensure regulatory compliance with QSR, and other regulatory requirements as appropriate through customer complaints, internal audits and training systems Assist in developing procedures to ensure regulatory compliance Maintain FDA and international device listings and establishment registration Assist with regulatory database development and maintenance Assist management with recall activities. Requirements What You Need to Achieve It: Bachelor's degree or equivalent, preferably in a scientific or technical discipline. Currently enrolled in a Masters degree program in Regulatory Affairs Experience with IDE, PMA and 510(k) preferred. Working knowledge of FDA regulations preferred. Regulatory Knowledge and Application Clearly communicates technical information for the audience for which it's intended; assimilates technical information rapidly through effective listening Demonstrates knowledge of domestic laws, regulations, guidelines and standards related to commercialization and post market surveillance of products. Demonstrates proficiency in preparing and submitting domestic regulatory submissions and documentation for product market approval. Supports and may develop comprehensive product approval recommendations that comply with regulatory requirements in support of product market approval. Applies working knowledge of internal policies and procedures, e.g., Regulatory Affairs, Quality Assurance, CAPA, SOP's, Product Development Plans, and Medical Reviews. Technical, Scientific, Clinical Knowledge Understands and interprets technical, scientific and clinical information and applies that understanding to product approval activities. Demonstrates knowledge of clinical and technical concepts and applications related to Organogenesis products. Translates, interprets, and applies technical, scientific, clinical, and promotional information. Provides feedback and offers solutions to technical, scientific, and clinical issues to support product development activities. Demonstrates knowledge of clinical trial design in support of regulatory requirements. Collaborates effectively with medical affairs, pre-clinical, and clinical functions to support regulatory requirements. Project Management Understands and effectively uses internal/external regulatory systems and processes involved in meeting regulatory requirements for Organogenesis products. Provides domestic regulatory expertise for regulatory projects. Identifies and escalates potential solutions to obstacles that impede project progress. Assists management with the execution of the functional deliverables associated with Project Management, and Quality Systems. Applies tools effectively to ensure individual project components meet overall cost, schedule, and performance requirements. Understands impact of own project and/or technologies on other projects within department. Business Partnering Takes an active role in building customer relationships, both internal and external to increase the credibility and image of Organogenesis and the Regulatory function. Participates with cross-functional teams for product development. Anticipates customer requirements and responds to these needs promptly and effectively while maintaining effective relationships with both internal and external customers. Solicits critique of regulatory strategies from internal customers We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, genetic information or any other characteristic protected by law. Organogenesis

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