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.    End of August/Early September start date-one day per week on site in Canton, MA required 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.