Job Title: Director Or Compliance And Regulatory
Type of Company: I work for a medical device contract manufacturing company in the Worcester, Massachusetts area.
Education: BS, Business Management, University of Phoenix
Previous Experience: I worked at a biotech company for 15 years performing a variety of functions. I was an order manager for ten years before I moved to Quality and Regulatory.
Job Tasks: My job is to ensure that my company is compliant with the good manufacturing practices regulation of the Food and Drug Administration (21 CFR Part 820). The objective of the regulation is make sure that medical device companies produce and sell safe and effective medical devices. I read the regulations and then develop procedures that employees use to manufacture medical devices. I am also responsible for monitoring the quality of the devices that are produced, using statistical methods to see if there is an issue anywhere along the supply chain of the device. When and if I find one, I am responsible for ensuring that the issue is satisfactorily resolved. Another really important element of my job is having to be audited by the FDA and other regulatory authorities periodically. I monitor and report quality data to the upper management on a monthly and quarterly basis so that upper management is aware of the quality of the products being produced.
Best and Worst Parts of the Job: The best part of my job is that I feel I am making a difference. Everyone at one time or another will either need a medical device or know someone that does. I make sure that the devices are safe and effective so that if you or a loved one ever needs a medical device, it will work like it should.
The worst part of my job is the stress that comes with it. There is a lot of responsibility and sometimes no matter how hard you work, an auditor can come in and find something that you forgot or find something that you can do better.
Job Tips: My advice would be to get experience working at different organizations and with different classes of medical devices. One of the pitfalls of staying at one organization for many years is that you will not get the wide-ranging exposure you need to truly gain an understanding of the regulatory framework. The regulations can be interpreted and implemented differently depending on what type of medical device is being manufactured. It is good to learn how different companies achieve the same goal.
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