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The Program Manager, Regulatory Affairs manages the regulatory aspects of biotechnology-derived products, including applications submitted to the FDA and other regulatory agencies. This individual will lead the US Regulatory Affairs program for development of multiple cell-based products for submission of 510(k), PMA and PMA-S. This includes leading the preparation and submission of any IDE BLA applications. Working with cross functional collaborators (such as R&D and Quality) and external consultants, this individual will also advise on regulatory and scientific issues related to the development of these products. This individual must have proven experience with successfully leading and writing submissions and expertise in regulatory scientific aspects preferably with biotechnology-derived products. This individual will also interface directly with governmental personnel and regulators, including scientific reviewers, administrative staff, and management to facilitate the review and approval of regulatory applications and ensure regulatory compliance. This includes preparing for and participating in meetings with FDA and the development of meeting briefing packages.
This position will also provide regulatory leadership and partner with other departments (Operations, Quality, Medical, Marketing, etc.) to support multiple platforms and product lines for commercialization and post-marketing activities. This will require the development of effective proactive regulatory strategies and tactical execution of regulatory activities for product lifecycle management including product development, commercialization, and post-marketing. Will recommend such strategies to the Vice President, Regulatory Affairs, Team Members, and/or Supervisor, as appropriate, with limited oversight. This position is based at Organogenesis's headquarters in Canton, MA
ABILITIES AND SKILLS REQUIRED: • Strong oral and written communication skills, and negotiation skills • Willing to set and drive aggressive project timelines • Capable of strategic thinking and proposing innovative solutions to regulatory problems • A team player, who listens effectively
JOB REQUIREMENTS: • Bachelor’s degree in a scientific discipline • At least 5 years' experience in the medical or life science industry with at least three years of increasingly responsible experience in Regulatory Affairs • Solid working knowledge of device/biologic development process and of FDA regulatory requirements for biotechnology products in the U.S. • Must have successfully submitted regulatory filings to the FDA and other regulatory agencies, including 510(k), PMA, PMA-S, and MDR submissions. Experience working on INDs and BLA submissions preferred • Experience with technical aspects of product development and manufacturing.
Internal Number: 692
Organogenesis is a leading regenerative medicine organization focused on empowering healing through the development, manufacturing and sale of products for the advanced wound care, surgical and sports medicine markets. We are committed to provide an integrated portfolio of healing solutions that improve lives while lowering the overall cost of health care. We empower clinicians with the full range of products and tools they need to heal patients and achieve better health outcomes.