dcsimg

Career Story: Director Of Compliance For A Medical Device Manufacturer

Director Of Compliance For A Medical Device Manufacturer

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.

Popular Schools offering Management Programs

quickinfoThese schools offer particularly quick info upon request, and we have written detailed profiles for each (click school names to see the profiles).

Request info from multiple schools, by clicking the Request Info links.

Matching School Ads
  • Programs: MS - Management, MS - Organizational Leadership
  • Degrees: Master

Why earn your degree at Grand Canyon University? GCU is a regionally accredited university offering graduate and undergraduate degrees in Business, Nursing, Psychology, Education & more. Apply today!

  • Programs: B.S. in Applied Management, M.B.A.: Leadership, M.B.A. and M.S. in Leadership (Dual Degree), more...
  • Degrees: Bachelor, Master

You've found Ashford University, where school comes to you. Earn your bachelor's or master's degree online.

  • Programs: BA/Organizational Management - No Concentration, MA/Organizational Management, MA/Organizational Management - Human Resources Management, more...
  • Degrees: Bachelor, Master

Lower Tuition Cost Than Many Other Universities.  Classes Start Soon.

  • Programs: Bachelor of Science in Management, Master of Business Administration in Management, Master of Arts in Human Dynamics, more...
  • Degrees: Bachelor, Master, Associate

Baker College is proud to be the largest independent college in Michigan with the most focused approach to education and training available. With one of the highest graduate employment rates in the country, our mission is to help our students find meaningful employment.

  • Programs: Leadership Studies - MBA (Master's), Business Administration - Associate, Business Intelligence - MBA (Master's), more...
  • Degrees: Master, Associate, Doctorate, Bachelor

Liberty University provides a world-class education with a solid Christian foundation, equipping men and women with the values, knowledge, and skills essential for success in every aspect of life.

  • Programs: DBA in Project Management, AA in Business, MA: Executive Leadership, more...
  • Degrees: Doctorate, Associate, Master

The goal of earning a master’s degree should be defined by you, not by your circumstances. No matter which path you’ve chosen, a graduate degree can help you advance with your current organization, explore opportunities with a new company, or even start fresh in a new industry. When you earn your master's degree, you’re opening new opportunities for career development that can make a difference for you and your family. Through flexible class scheduling, dedicated career advisors and quality programs, NAU strives to provide a caring and supportive learning environment to ensure your success as a student.

  • Programs: Master of Business Administration, Aviation Management , Master of Business Administration
  • Degrees: Master

Pursue your education at Pacific Oaks College.

  • Programs: M.A. Organizational Leadership and Change
  • Degrees: Master

Congratulations! Your interest in Independence University is an important first step toward changing your life. A career-focused degree is the key to a career with a potentially higher income, better benefits, and more satisfaction.

  • Programs: Business Administration (BS)
  • Degrees: Bachelor
California College San Diego
National City, San Diego, San Marcos

The Secret to Getting Ahead is Getting Started

  • Programs: Business Administration - Property Management (BS), Business Administration (BS)
  • Degrees: Bachelor
Matching School Ads

Additional Career Stories for Managers

The inside stories from people actually working in the field.
Click a story title to show the story, and click the title again to hide it.

All Types

You are visiting:

Find a school near you

What are Career Stories?

Career Stories are concise, real-world career overviews written by people relating their personal career experiences and wisdom. They provide invaluable insights and mentoring advice to students and career changers.

Most stories include:

  • a typical day or project
  • tips and advice
  • best and worst parts
  • educational background
  • previous experience

Browse hundreds of Career Stories

More Details On This Career

Please also see our detailed information about Managers, including:

Back to Top