Amanda (Mandy) Klosterman Email & Phone Number

Greater Minneapolis-St. Paul Area

I provided strategic consulting for the medical device industry in the area of rapid study site activation of clinical trials and compliance related services. RCRI’s Rapid Site Activation is a proven process that reduces time-to-market and includes contract drafting and negotiation with sites, consultants, and core labs, and management and development of study budgets in compliance with the principles of fair market value. In addition, I also assist clients in developing compliance programs, including risk assessments, drafting policies and procedures, and development of employee training programs related to industry relationships with physicians and health care organizations, including the implementation of the federal Sunshine Act. I received my law degree from William Mitchell College of Law in St. Paul and most recently served as Senior Legal Specialist at Medtronic, Inc., a Fortune 500 medical device company, headquartered in Minnesota. I have over 30 years in the legal field, including 15 years of expertise in healthcare law including issues related to clinical research, regulatory affairs, medical device reimbursement, acquisition due diligence review and integration activities. Previous experience includes private law firm practice handling products liability and commercial litigation.

Greater Minneapolis-St. Paul Area

RCRI is a leading provider of strategic consulting and integrated clinical trial services to the medical device, IVD, biologics, and combination product industries. Services include Clinical Research, Regulatory and Quality Systems, Health Economics & Reimbursement, and Compliance. For more than a decade, RCRI has been turning medical product concepts into successful, revenue-generating businesses for clients worldwide. We look at every angle of the project entrusted to us, offering the value of our combined experience, insight and foresight to create comprehensive interdisciplinary solutions. By creating a collaborative partnership with our clients, we achieve great results together. RCRI is ISO 9001:2008 certified.

Minneapolis, Mn

• Legal partner with the medical device company functional departments within Neuromodulation (1998-2008) and Corporate (2008 – Feb 2012) including clinical research, regulatory affairs, reimbursement, sales, marketing, quality, product development, supply chain, and manufacturing.• Close working relationships with the Vice Presidents of the departments including a valuable team member on the senior staff, all other levels of management (Directors and Managers) and their staff.

Greater Minneapolis-St. Paul Area

• In-house counsel for an international manufacturing company with emphasis in products liability, contracts, warranty and construction law.• Manage outside legal counsel for litigation matters including discovery strategies and compliance, settlement opportunities, alternative dispute resolution options, and trial support.

St. Paul Mn

• Primary responsibility for all stages of pretrial litigation including drafting pleadings and discovery, taking depositions, research and writing motions and memoranda of law.• Court appearances including arguing motions, pretrial and settlement conferences, jury and bench trials.• Manage and supervise teams of attorneys, paralegals, and staff in large cases.• Consistent effectiveness in planning complex projects from issue analysis through implementation and completion in designated time frame.1981 - 1988: litigation paralegal.

Doctor Of Law (Jd)

Paralegal