Ashley Hutchison

About Ashley Hutchison

With over seven years of work experience in the medical device industry, I am a passionate and dedicated post market surveillance specialist who strives to ensure patient safety and compliance with regulatory requirements. I have a master\'s degree in business administration with a focus on healthcare, and I have developed expertise in industry standards, problem solving, and communication. I am currently working at Smith & Nephew, a global leader in advanced medical technologies and solutions.At Smith & Nephew, I produce various reports and plans that monitor and evaluate the performance and safety of the company\'s products in the market. I collaborate with cross-functional teams, such as quality, engineering, clinical, and regulatory affairs, to collect and analyze data, identify trends and issues, and implement corrective and preventive actions. I also ensure compliance with relevant regulations and standards, such as ISO 13485, MDR, and FDA.

Experience

1. Senior Post Market Surveillance Specialist

   Smith Nephew

   Oct 2019 — Present

   Produce PSURs (Periodic Safety Update Reports), PMDARs (Post Market Data Analysis Reports), PMS Plans (Post Market Surveillance Plans), and PMSR (Post Market Surveillance Reports).

Education

• Saint Louis University

  Bachelor of Science, Health/Health Care Administration/Management

  2013 — 2015

• Christian Brothers University

  Master of Business Administration - MBA, Healthcare

  2017 — 2019