Erin Mazzone

Vice President, Regulatory And Quality at Elixir Medical Corporation

Erin Mazzone has extensive work experience in the field of regulatory affairs and quality management in the medical device industry. Erin has held various leadership roles in both start-up companies and established organizations.

At Elixir Medical Corporation, Erin served as the Vice President of Regulatory and Quality. Their responsibilities included developing global regulatory strategies, managing submissions, and ensuring compliance for a range of vascular solutions, including high-risk drug/device combination vascular implants.

Prior to their role at Elixir Medical Corporation, Erin was the Vice President of Regulatory Affairs for the same company. Erin was responsible for global regulatory strategy, submissions, and compliance for innovative vascular solutions.

Before joining Elixir Medical Corporation, Erin worked at MAQUET Cardiovascular as the Director of Regulatory and Director of Regulatory, Clinical, and Reimbursement. In these roles, they oversaw the regulatory, clinical, and reimbursement departments for a newly expanded division. Their team was responsible for the transfer of registrations and clinical studies from Guidant and/or Boston Scientific to MAQUET.

Erin also held positions at Guidant Cardiac Surgery, RITA Medical Systems, Cardiac Pathways, Cardiometrics, and Accuray, where they gained experience in regulatory affairs, quality control, compliance, and international submissions.

Overall, Erin Mazzone has a strong background in regulatory affairs and quality management, with a focus on developing global regulatory strategies, managing submissions, and ensuring compliance for medical devices in the vascular and cardiac fields.

Erin Mazzone obtained a Bachelor of Science degree in Bioengineering from UC San Diego, where they attended from 1988 to 1993.

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Previous companies

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Timeline

  • Vice President, Regulatory And Quality

    October, 2020 - present

  • Vice President Regulatory Affairs

    May, 2018

  • Senior Director Regulatory Affairs

    January, 2012