Jim Luker, VP of Regulatory Affairs

Jim Luker


Joined: September 19, 2022


Registered Nurse (licensed since 1991) medical device regulatory affairs quality management systems


I see myself as a husband, father and friend. I have been married for 30 years to my best friend’s sister (Beth-an), have two awesome grown children (Alec & Elizabeth) and have an adopted cat (Bonnie). My passion for medical device regulatory affairs developed from my 10 years of work as an RN in an Intensive Care Unit and Cardiac Catheterization laboratory. I have worked in the medical device industry for over 20 years and have taught regulatory affairs at the graduate level for 8 years. Currently, I am mainly involved in regulatory strategy and submissions for software medical devices (SaMD). I have been with Innolitics for several years and am thrilled to work with such an excellent and dedicated team!


Reading (science, philosophy), weight training, swimming and archery