Be fearless: seize the opportunities that scare you the most | Kimberly Trautman
06/23/21 • 50 min
Key takeaways:
- Learn how to SEIZE the opportunities that scare you the most
- Why you should take on CHALLENGES as early as possible in your career
- The VALUE in networking rigorously
- Make your HEALTH a priority in work life
About Kimberly Trautman:
Kimberly A. Trautman is an experienced Medical Devices, InVitro Diagnostics, and Combination Product Expert with over 30 years of experience. She worked at the US Food and Drug Administration (FDA) for 24 years and continues to work with Regulatory Agencies around the globe. Industry experience as well as regulatory agency experience.
Demonstrated history of working collaboratively with industry, regulators and patient groups for the betterment of public health. Executes several medical device regulatory services and developed a formal Education/Training business. Established an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body for EU IVDR/MDR Designation.
Expert in global medical device regulations, wrote and harmonized the current US FDA Quality System Regulation and was on the international authoring group of ISO 13485 since inception. Conceived and developed the Medical Device Single Audit Program and its consortium of five Global Regulators. Twenty-year veteran of the Global Harmonization Tasks Force (GHTF) and foundational member of the International Medical Device Regulators Forum (IMDRF). Recognized International Medical Device expert with a Master's Degree in Biomedical Engineering.
Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.
Key takeaways:
- Learn how to SEIZE the opportunities that scare you the most
- Why you should take on CHALLENGES as early as possible in your career
- The VALUE in networking rigorously
- Make your HEALTH a priority in work life
About Kimberly Trautman:
Kimberly A. Trautman is an experienced Medical Devices, InVitro Diagnostics, and Combination Product Expert with over 30 years of experience. She worked at the US Food and Drug Administration (FDA) for 24 years and continues to work with Regulatory Agencies around the globe. Industry experience as well as regulatory agency experience.
Demonstrated history of working collaboratively with industry, regulators and patient groups for the betterment of public health. Executes several medical device regulatory services and developed a formal Education/Training business. Established an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body for EU IVDR/MDR Designation.
Expert in global medical device regulations, wrote and harmonized the current US FDA Quality System Regulation and was on the international authoring group of ISO 13485 since inception. Conceived and developed the Medical Device Single Audit Program and its consortium of five Global Regulators. Twenty-year veteran of the Global Harmonization Tasks Force (GHTF) and foundational member of the International Medical Device Regulators Forum (IMDRF). Recognized International Medical Device expert with a Master's Degree in Biomedical Engineering.
Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.
Previous Episode
Being a serial entrepreneur | Max Boysset, Inventor, CEO and entrepreneur
Key takeaways:
- How to be a SUCCESSFUL serial entrepreneur
- Why it pays to have a fascination with product SOLUTIONS
- How the next great IDEAS are formed
- What INSPIRES Max and what we can all learn from this
About Max Boysset :
Max has founded several companies. He has been the CEO of IcosaMed since 2019 and the CEO of SAV-IOL since 2014. In 2014 he also co-invented Sterilux. He is fascinated by product idea solutions and is what we can call a "serial entrepreneur".
Max's experience stretches from big international companies to creating start-ups. He has 20 years' experience as an industrial pharmacist (PhD) with proven track records in the pharma, bio-pharma, and medical device sectors.
For him, being a successful entrepreneur is getting the balance right between knowledge, experience and (potential) initiatives. According to Max, what you need to be an entrepreneur is: courage, effort, determination, uncompromising behavior, accepting failures, accepting support, the ability to cope with loneliness, humility, and BEING YOURSELF!
Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.
Next Episode
The power of resilience: from redundancy to CEO | Liam Turley, CEO at Trinzo
Key takeaways:
- Learn about Liam’s EPIC comeback journey to success
- The VALUE of being able to start from scratch
- The art of PRIORITISATION and why this is needed
- We can all be INSPIRED by Liam’s career journey
About Liam Turley:
Liam is the CEO and Quality Expert at Trinzo and is based in Galway, Ireland. Liam brings deep executive experience in quality and regulatory strategy and improvements, with a track record of comprehensive quality performance improvement.
Liam has worked with the medical device and pharmaceutical industry for over 25 years, including with companies such as Tyco Healthcare, Mallinckrodt, Covidien and Medtronic. Prior to founding Trinzo, Liam was a global vice president of quality assurance with Medtronic. Liam has worked and lived in the United States and the Netherlands and has managed teams globally. Liam has led global initiatives in the area of medical device and combination products.
Liam has expertise in the area of quality remediations and leads companies successfully in resolving notified body major/critical findings, 483s, warning letters and consent decrees. Liam also has extensive MDR expertise and understands the client’s needs for a pragmatic approach. He has liaised with multiple notified bodies, competent authorities, the FDA, and ministries of health around the globe.
Liam holds a bachelor’s degree in microbiology and an MSc in biotechnology, in addition to a postgraduate diploma in pharmaceutical manufacturing.
Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.
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