Melanie - Senior Director of Regulatory Affairs - CRDM


Senior Director of Regulatory Affairs
Mounds View, MN

Describe a typical day in your position.

My typical day involves attending many meetings, such as those for Brady, Tachy or Heart Failure therapy; the MRI Delivery group; and specific devices such as Evera MRI ICD to discuss Regulatory strategy. I also have 1:1s with each of my direct reports and extended staff members. And, I walk around the Regulatory department to check in to see how people are doing on a professional basis as well as a personal basis.

What do you love about your job?

I love the intelligent, motivated and passionate people I work with and, of course, the Medtronic Mission statement! I enjoy getting medical devices approved around the world, knowing these devices have a huge impact on people's lives.

What is challenging about your job?

The challenge about my job is determining the best strategy for meeting global regulations for each medical device. Our goal is to determine the fastest pathway to getting the devices approved so patients have access to the latest technology Medtronic has to offer.

What do you appreciate most about Medtronic?

I appreciate that Medtronic has so many medical devices that we are working on to improve people's lives, starting with pacemakers and expanding to defibrillators, CRT devices, heart valves, stents, neurostimulators, devices for diabetes, and the list goes on! Medtronic is a huge medical device business, and I'm proud to be contributing to it.

How do you give back?

I give back by mentoring people and having many informational meetings with people on their career paths. This fall, I will be one of the instructors at the University of Saint Cloud Master's program in the Regulatory Affairs Science program. Also, I am a Sunday school teacher, and I participate in the Silent Auction program at my children's elementary school.

What is one random fact about you?

I love outdoor activities such as camping, hiking and fishing.

How do you balance your life?

I work hard, but I also play hard! I make sure I am accountable to my job and complete work assignments I've committed to do. I attend my children's activities and am involved in their lives, and I also make sure to spend quality time with my husband… maybe a date here and there! My work is very important to me, but focusing on my family is also very important, and I make sure that's at the top of my list.

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