Heather Nigro
About Heather Nigro
Heather Nigro serves as the Senior Vice President of Regulatory, Quality, and Clinical Affairs at CSA Medical Inc, where she has worked since 2019. She possesses extensive experience in regulatory affairs within the medical device industry, having held various leadership roles at notable companies such as Covidien and NxStage Medical.
Work at CSA Medical
Heather Nigro serves as the Senior Vice President of Regulatory, Quality, and Clinical Affairs at CSA Medical Inc. since 2019. In this role, she holds overall responsibility for regulatory, quality, and clinical affairs functions for the truFreeze commercial business and the RejuvenAir investigational device. Her work involves developing and executing global regulatory and clinical strategies throughout the life cycle of medical devices, with a focus on ensuring compliance with both US and EU market requirements.
Previous Experience in Regulatory Affairs
Heather Nigro has extensive experience in regulatory affairs within the medical device industry. Prior to her current position, she worked at NxStage Medical, Inc. as Vice President of Regulatory and Clinical Affairs from 2015 to 2019. She also held various roles at Covidien, including Senior Director of Regulatory Affairs for Early Technologies, and Senior Manager of Regulatory Affairs. Additionally, she served as Associate Director of Regulatory Affairs at Bristol-Myers Squibb Medical Imaging and as a Regulatory Affairs Specialist at Anika Therapeutics, Inc.
Education and Expertise
Heather Nigro studied Industrial Hygiene and Work Environment at the University of Massachusetts Lowell, where she earned a Master of Science degree from 1998 to 2000. She also holds a Bachelor of Science degree in Marine Safety from Massachusetts Maritime Academy, which she attended from 1992 to 1996. Her educational background supports her expertise in regulatory affairs, quality system requirements, and clinical strategies in the medical device sector.
Background in Medical Device Industry
Heather Nigro has a strong background in the medical device industry, with a focus on acquisition integration and due diligence review. Her career spans over two decades, during which she has developed a comprehensive understanding of FDA and other regulatory agency communication and negotiation. This experience has equipped her with the skills necessary to navigate complex regulatory landscapes and ensure compliance for medical devices.
Specialization in Cryotherapy Technology
In her current role at CSA Medical, Heather Nigro is involved in understanding the functionality of metered cryospray technology, which is designed to rejuvenate airways. This innovative approach aims to enhance the quality of life for patients by providing effective treatment options. Her expertise in regulatory and clinical affairs plays a crucial role in the development and implementation of this technology.