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

quickinfoClick the Visit School Site buttons to go directly to a school's website and learn more about the school and programs it has to offer. School website will open in a new tab. .

Click the Request Info buttons to request more information from a representative at the school

Matching School Ads

The Forbes School of Business® combines the power and flexibility of online learning with high-quality, topical Forbes content.

  • Programs: BA Operations Management and Analysis, MA Organizational Management - Supply Chain Management Specialization, MA Organizational Management - Public Administration Specialization, more...
  • Degrees: Bachelor, Master
Platt College
Alhambra, Riverside

Turn your talents into a career at nationally recognized and accredited Platt College.

  • Programs: Business Management
  • Degrees: Associate
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

Pursue your education at Ohio Christian University.

  • Programs: Associate of Arts in Business - Business Management, Bachelor of Arts in Business - Business Management, Bachelor of Arts in Business - Organizational Leadership, more...
  • Degrees: Associate, Bachelor, Master

American University’s Kogod School of Business has been educating business leaders since opening its doors in 1955 as Washington D.C.’s first university-level school of business.

  • Programs: MBA
  • Degrees: Master

Pursue a certificate, master, or doctorate degree in Psychology at The Chicago School for Professional Psychology.

  • Programs: Ph.D. Organizational Leadership
  • Degrees: Doctorate

MBA@Syracuse is the top-ranked online Master of Business Administration from the Whitman School of Management at Syracuse University.

  • Programs: Master of Business Adminitration (MBA)
  • Degrees: Master

Since 1888, The University of Scranton has grounded its education in Catholic and Jesuit principles based on intellectual growth and integrity, all of which shape the online master’s and certificate programs.

  • Programs: MBA - Operations Management, Master of Business Administration, MBA - Enterprise Resource Planning
  • Degrees: Master

Pursue your education at Pacific Oaks College.

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

Earn your graduate degree online with Northcentral University.

  • Programs: Management - D.B.A., Management - BBA, Management - PhD in Bus. Admin., more...
  • Degrees: Doctorate, Bachelor, Master
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:

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