hero header image Kimberly Trautman | Be fearless: seize the opportunities that scare you the most | Elemed



Kimberly Trautman | Be fearless: seize the opportunities that scare you the most

😱 Be Fearless: Seize the Opportunities That Scare You the Most

Our guest today is none other than Kim Trautman – Medical Device, IVD, and Combination Product Regulatory & Quality Expert with over 30 years’ experience in the Medical device industry. We are excited to hear from her on her experience both in production and regulation, her highlights as well as things she could have done better, and her advice to young professionals and entrepreneurs seeking to join the MedTech industry.

📚 Introduction

Kim began her career back in the 80s working through campus whilst simultaneously serving in the army. In between breaks she worked at B. Braun in quality assurance testing and manufacturing. After four successful years at B. Braun in Pennsylvania, she joined USPTO as a Biotechnology Patent Officer. This was before her ground- breaking years at the FDA, where she served for 24 years as Associate Director International Affairs at the Office of the Centre Director, CDRH. She currently serves as Director of the Board of Directors at the Regulatory Affairs Professionals Society while working at the Penn State university college of engineering. 

🚪 Picking A Career Path

She knew for the longest time that she had a passion for MedTech, which is what fueled her undergraduate and Master’s studies. Her initial years at B.Braun gave her a taste of regulation which is something she grew to love. Working hands-on allowed her to know what she enjoyed doing and what she did not. 

Your initial work experience should enable you to know what you like vs. what you don’t so that you can follow the compass of your passion. Jump at every opportunity you get because that allows you to get a feel for many things in a short space of time. You’re then in a much better position to know what your preferences are.

🤔 On the Role of Personal Choice

Kim believes that a career is the sum total of many personal decisions that an individual makes. She made the decision, for example, to take on challenges as early on in her career as possible and to network rigorously. All these personal choices played a role in getting her to where she is now. 

🇺🇸 Taking That Bold Step - A Career Defining Decision

Back in the early 90s while working at the FDA, she took a leap of faith and asked her boss to allow her to join the international standards team. This brave move gave her access to a wealth of knowledge and opportunities – a move she is really glad she made. She urges young professionals to be brave and not hesitate in joining teams they feel they are not qualified to be part of. At worst you will learn some important lessons and at best you may emerge the leader. Offer your experience and your time, and choose to learn.

🤝 On Workplace Relations

Your network is your net worth. You are only as rich as all the people you know put together. Do not be afraid to hand out home-cooked lunches or engage in workplace friendships. Networking will open doors for you that experience alone may not. 

Looking back, Kim cannot point out any opportunities she regrets making. She has always been bold in her pursuits and has never hesitated to reach out for help or be part of tasks out of her perceived league.

☑️ The Long Stint at FDA

Kim attributes her long career at FDA to a combination of factors. Firstly, she was very fortunate to work with a team that included her husband. She found the environment very supportive for personal as well as professional growth. She was also able to achieve a good work-life balance at a very young age. One of the benefits she had at FDA was the ability to work from home a few days a week, back when remote working was uncommon.

👔 On Career Changes

According to Kim, careers are all about the little decisions and actions that you go through. Don’t be rigid when faced with new challenges or new job descriptions. Even in instances where you feel you don’t quite meet the expectations of the role, try and you might just end up making the best decision of your professional life. 

🤝 Mentorship – The Card Every Deck Needs

Kim remains a firm believer in the importance of mentorship for personal and professional growth. She attributes who she is today to mentors who guided her from a young age, and believes there should be provision for career mentorship especially with there being so much talent in present times. Now that we have so much technology to work with, our focus should be on identifying and nurturing young minds that are passionate about the MedTech industry. 

She is also confident that with hard work, determination and perseverance women can take their place in the male-dominated fields of regulation and MedTech.

😓 Burnout and Self-Care

Kim experienced burnout this year, taking away an important learning from the experience – rest is just as important as work. She encourages professionals to find time and rest, take a shower, walk, soak in a bathtub. Make your health a priority because it is impossible to pour from an empty cup. 

🤲 Leaving a Legacy

Kim believes that so far, she has achieved a lot of what she set out to do at the very beginning of her journey. Her focus now is on mentorship and being able to pass her experience and knowledge on to the next generation. 

Say goodbye to wasting time and money on digitising your regulatory activities.


Arrange a callback

WE'RE Here To Assist You

Let’s get to know each other

Have a free, personalised, career consultation with one of our experts. Learn about under-the-radar opportunities, salary insights and develop your career plan.