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Program Manager, Regulatory Affairs

Organogenesis • Canton, MA, US • published 2026-10-02 15:58:45.782600

Description

Job Description: We have unique opportunities 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. We offer a strong benefits package, opportunities for growth, and the chance to contribute to our mission: to provide an integrated portfolio of healing solutions that improve lives while lowering the overall cost of health care. **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 products to the FDA and International regulatory bodies. This individual will also provide regulatory support and guidance for product changes to US marketed products. **How You Will Achieve It:** * Working closely with process development, manufacturing and quality departments to support the preparation of domestic and international regulatory submissions. This includes writing, reviewing, and editing ...

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