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Russ joined Experien Group in 2008 as the Executive Vice President and leader of the firm’s satellite office located in the Twin Cities region of Minnesota. Russ’s 35+ year medical device industry career includes 20 years experience advancing novel device technologies from start-up phases through commercialization. He possesses an extensive background in global product development for diagnostic and therapeutic devices, including active implantable devices and combination products. Russ has provided executive leadership and strategic advisory work for companies developing significant implantable cardiovascular and neuromodulation systems, laser therapies, drug pumps, heart valves, interventional cardiology products (including intravascular ultrasound and drug eluting stents) and other complex devices.
At Experien Group, Russ helps client companies to design and implement global regulatory, quality and clinical strategies for their medical device and combination product lines. He actively supports companies in the early development stage, the regulatory submission stage, and the post-market stage, including compliance considerations. He provides virtual staff executive leadership for several Experien Group clients. Russ’s areas of involvement include:
- Complex U.S. and international regulatory and clinical strategies
- Interface with U.S. and international regulatory agencies
- Advising on field actions, including advisory notices, recalls, and Department of Justice investigations
- U.S. and international regulatory submissions
- Pre-clinical testing
- Clinical trial designs
- Strategic partnerships for technological investments and corporate growth
- Compliance and vigilance reporting activities for products distributed in U.S. and international markets
PAST COMPANIES AND EXPERIENCE
Russ started his medical device career in 1972 as an FDA Investigator, conducting more than 300 inspections and investigations over his 5-year term. For approximately 30 years, he worked for medical device companies, including 10 years in senior management positions for large companies such as Medtronic and Boston Scientific. He additionally held executive positions at earlier stage companies, including: ATS Medical, GV Medical, Cardiovascular Imaging Systems, and EnteroMedics. Russ’s experience for start-up and mid-sized companies includes global pre-clinical, clinical, regulatory and quality strategy development and implementation. He has supported several companies through successful IPOs and secondary offerings.
EDUCATION
Russ received his BS degree in Chemistry from the University of Iowa. |
