Reporting to the Chief Operating Officer, this position is based at the Company headquarters in Canton, MA, approximately 20 miles south of Boston. The Senior Director, Regulatory Affairs leads the regulatory programs for Organogenesis’ regenerative cellular and tissue-based Wound Healing and Surgical & Sports Medicine product portfolios. This role requires the development of effective regulatory strategies and tactical execution of regulatory activities for product lifecycle management including product development, commercialization, and post-marketing. This role has primary responsibility for all pre and post-marketing submissions, reports and activities necessary for FDA and international product registration and regulatory compliance, including CMC-related submissions, periodic reports, incident reports, and license/registration maintenance. Additionally, this role includes responsibility for regulatory support and compliance of the Company’s tissue banking operations and licenses.
This individual will interface directly with agency staff, including scientific reviewers, administrative staff, and management to facilitate the review and approval of regulatory applications and ensure regulatory compliance. This position will provide regulatory leadership and partner with other departments (R&D, Operations, Quality, Medical, Marketing, etc.) to support multiple product platforms and product lines for commercialization and post-marketing activities. He or she will develop effective proactive regulatory strategies for global product development and will recommend such strategies to the cross-functional teams, and will be expected to lead, assess, coach, and develop a a multi-site regulatory affairs team.
BS degree in life sciences or related scientific discipline, advanced degree preferred.
10+ years' relevant experience in the medical device, biotech industry: minimum of 5 years leading regulatory affairs team(s) in the submission of regulatory filings to the appropriate entities and interactions with these agencies; prior experience from pre- to post-launch preferred including 510(k), PMA, international registrations and technical files.
Expertise in relevant regulations and standards for combination products (biologics/device) and familiarity with regulatory authorities.
Strong organizational, interpersonal and written/verbal communication skills required.
Experience with technical aspects of product development and manufacturing.
Ability to travel up to 15%.
Internal Number: 383
About Organogenesis, Inc.
Organogenesis Inc. is a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the advanced wound care, surgical and sports medicine markets. The company’s mission is to provide integrated healing solutions that substantially improve medical outcomes and the lives of patients while lowering the overall cost of care.
Organogenesis' versatile product portfolio is designed to treat a variety of patients with repair and regenerative needs across the continuum of care.
Organogenesis Inc. was originally founded in 1985 as a spin-off of technology developed at the Massachusetts Institute of Technology (MIT). In 2017, Organogenesis acquired NuTech Medical, which further expanded our wound care portfolio and introduced product solutions for the surgical and sports medicine markets.
Today, Organogenesis has approximately 600 employees worldwide and is led by a management team of talented individuals with more than 100 years of collective regenerative medicine experience. The Organogenesis corporate headquarters is located on our four-building campus in Canton, Massachusetts.