An Unexpected Career Path

For most of my career, I have worked in Regulatory Affairs.? Over my lifetime, whenever I have met someone new, whether it was a person at my partner’s work event, one of my kid’s friends’ parents, or my aunt’s new husband, I am asked what I do for a living. Typically, I simplify the details of my job as much as possible to move the conversation along to another topic.? I often say that I work for a medical device company in Regulatory Affairs.? I may clarify that my job is about “rules and regulations”.? Sometimes I might say that I am a “paper pusher”.? When it appears that the person is looking for more, I will add a little more detail, “In order to sell a medical device into a specific country, it requires regulatory approval.? So, I submit (or help submit) the application to get approval and then once approved, maintain that registration and keep the company in compliance.”? That explanation is usually sufficient, my job is categorized as boring, and we will move on to other topics such as do you have a dog, if so, what kind?? For those that are not immediately put off and show genuine interest, they will ask, “how did you get into that?”?

Well dear sir, that is a great question, because in meeting others in my chosen field, I found that the career wasn’t always chosen.? Sometimes, the career chose them. I have heard many say, including myself, “I kind of just fell into it.”? Regulatory Affairs was not a career that one would consider while I was going through high school or even college, 20 plus years ago.? There were no college degrees in this field, and it was not a well-known career path. In fact, I didn’t even know what it was or what I was supposed to do, when I moved into my first Regulatory Affairs position.? In attending conferences and seminars over the years and networking with other Regulatory Affairs professionals, I found this to be a common theme.?

Although my major in college was Chemistry, I was working on completing pre-pharm courses to go to Pharmacy School to obtain my J.D., to become a licensed pharmacist.? However, life happens, sometimes implodes and plans change.? I graduated with a B.A. in Chemistry and took a job as a Chemist on the graveyard shift.? My work included performing routine chemical testing.? Without a microbiologist on my shift, I performed Limulus Amebocyte Lysate (LAL) Assays.? For those that would have said, “that’s not my job”, it got me my next job working for my first medical device company on the day shift.? Do not turn down an opportunity to learn something new.? In my new role, LAL Assays became a majority of my daily tasks and sleep felt good.? After a couple of years in this role and at a company that wasn’t giving pay raises, I saw an opportunity when the Regulatory Affairs Specialist was leaving, and her position became available.? Assuming the position paid more than I was being paid at that time, I immediately went to my manager and told him, “I don’t know what she does, what regulatory affairs is, but I want her job.”? He told me that he was going to ask me anyways.? Perfect! “When you are asked if you can do a job, tell ‘em, ‘Certainly I can!’ Then get busy and find out how to do it.” – Theodore Roosevelt.

Shortly after the decision was made that I was moving into the Regulatory Affairs Specialist role, the CFO of the company told me that I should take some classes at UCI Extension to learn more about medical device regulations and that the company would pay for it.? Not only did I get a raise and a title change, but this was also another opportunity to learn, and I took it.? This became the beginning of my 20+ year career in Regulatory Affairs.

Over the years, things have changed in education.? There are now Bachelors, Masters and Certification programs in Regulatory Affairs.? There are so many opportunities to learn and as a professional in this field, you are doing yourself a disservice not to learn as much as you can, especially if your company is footing the bill.? Attend Regulatory Affairs conferences and seminars.? Not only is this a great opportunity to learn about changes in regulations and compliance, but it is also a great opportunity to network with others in your field who may be interviewing you for your next big role.? If you are asked to take on additional responsibility, say yes. If you do not have industry experience while going to college, look for an internship.? Often that company will hire you upon graduation.? Even with a master’s degree in Regulatory Affairs, it is unlikely that you will land a manager position without any industry experience.? Keep your standards high but keep your expectations reasonable.

For the record, Regulatory Affairs is not boring.? Regulations and rules of compliance are always changing and the opportunity to learn never stops.? It is a job that is fast paced and keeps me on my toes.? Do I regret not going to Pharmacy School?? No, not at all.? In retrospect, I would have been bored out of my mind counting pills and the work schedule would not have been ideal raising my children as a single mom.? Over the years, I have often told myself and my children, it may not always feel like it in the moment, but everything always works out for the best in the end. I love what I do, it has given me purpose and I believe that I am making a difference in the medical device industry. #RegulatoryAffairs #Compliance #Regulations #Neverstoplearning

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