Heather Nigro

Heather Nigro has a diverse work experience spanning over two decades. Heather began their career as a Consultant at ENVIRONMENTAL HEALTH AND ENGINEERING in 1997, where they conducted toxicological assessments and managed the fit-testing program for respirators. From 2000 to 2005, Heather worked at Anika Therapeutics, Inc. as a Regulatory Affairs Specialist, responsible for maintaining FDA and International establishment listings and device registrations, as well as preparing regulatory filings and participating in inspections.

In 2005, Heather joined Bristol-Myers Squibb Medical Imaging as a Manager in Regulatory Affairs, where they collaborated with the full development team and international partner to develop a Class III intracoronary catheter system. Heather also facilitated medical device training and integrated quality systems. Heather was later promoted to Associate Director - Regulatory Affairs, where they served as the primary liaison for regulatory bodies and provided strategic guidance for product development teams and marketed products.

Heather joined Covidien (now Medtronic Minimally Invasive Therapies Group) in 2008 as a Senior Manager in Regulatory Affairs, responsible for biosurgical product line support and managing international registrations. In 2011, they became the Director of Regulatory Affairs for the Soft Tissue Implant Franchise, overseeing regulatory support for the Biosurgical and Hernia Mesh product lines.

From 2013 to 2015, Heather held two roles at Covidien. Heather was a Senior Director of Regulatory Affairs, responsible for regulatory teams and strategies in the Gastrointestinal, Interventional Lung, and Advanced Ablation divisions. Heather also provided regulatory guidance for diligence projects and acquisition integration.

In 2015, Heather joined NxStage Medical, Inc. as the Vice President of Regulatory and Clinical Affairs, leading regulatory strategies for End Stage Renal Disease (ESRD) products. Heather analyzed regulatory agency activities and advised senior management on potential impacts to the business.

Heather's most recent position is with CSA Medical Inc, where they currently serve as the Senior Vice President of Regulatory/Quality/Clinical Affairs, a role they have held since 2019. Overall, Heather Nigro has extensive experience in regulatory affairs, quality assurance, and clinical affairs within the medical device and pharmaceutical industries.

Heather Nigro's education history includes a Bachelor of Science (BS) degree in Marine Safety, which they obtained from Massachusetts Maritime Academy between 1992 and 1996. Following that, they pursued a Master of Science (MS) degree in Industrial Hygiene, Work Environment at the University of Massachusetts Lowell from 1998 to 2000. Prior to their higher education, Heather attended Whitman Hanson Regional High School from 1988 to 1992, although the specific degree and field of study during this time are unknown.

In addition to their academic achievements, Heather Nigro also obtained a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society in November 2002.