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Rac Mira Leiwant
Rac Mira Leiwant
Vice President Regulatory Affairs, Clinical Affairs and Quality Assurance | Anika
Boston, Massachusetts, United States
Rac Mira Leiwant
Summary
Rac Mira Leiwant is an accomplished Vice President with extensive expertise in regulatory affairs, clinical affairs, and quality assurance within the pharmaceutical and medical device industries. With a strong educational background in Mechanical Engineering and Bioengineering from Cornell University, Rac has successfully led teams in developing and implementing regulatory strategies for complex Class II and III products across global markets. They have a proven track record of managing cross-functional teams and ensuring compliance with rigorous standards such as ISO 13485 and FDA regulations. Rac's leadership experience spans various organizations, where they have been instrumental in driving product development and quality initiatives. Their strategic insights have significantly contributed to the successful launch of numerous medical devices and drug/device combination products. Additionally, Rac is known for their ability to navigate complex regulatory landscapes, making them a valuable asset in any organization aiming for innovation and compliance in healthcare.
Rac Mira Leiwant
Work Experience
Vice President Regulatory Affairs, Clinical Affairs and Quality Assurance at
Anika
November 2019 - Present
Vice President, Regulatory Affairs at
Boston Scientific
November 2016 - November 2019
Senior Director, Quality Engineering and Regulatory Affairs at
Acelity
March 2013 - November 2016
Director, Quality Engineering at
Lifecell Hair Restoration
March 2013 - April 2014
Director, Quality Assurance at
Svelte Medical Systems, Inc.
March 2011 - March 2013
Director of Quality Assurance at
Vascular Therapies
March 2009 - February 2011
Consultant at
Micell Technologies, Inc.
January 2010 - January 2011
Product Director, Global Strategic Marketing at
Johnson & Johnson
January 2008 - December 2008
Manager Health Care Compliance at
Cordis
September 2007 - December 2007
Quality Assurance Manager, Promotional Review at
Cordis
October 2005 - August 2007
Manager, Quality Assurance at
Cordis
March 2003 - October 2005
Sr. Quality Engineer, New Product Development at
Cordis
June 2001 - March 2003
New Product Development Engineer at
Cordis A Johnson And Johnson
January 1998 - January 2001
College Intern at
Muro Pharmaceuticals
January 1994 - January 1997
Rac Mira Leiwant
Education
Cornell University, Master Of Engineering
January 1997 - January 1998
Cornell University, Bachelor Of Science
January 1994 - January 1997
Frequently Asked Questions about Rac Mira Leiwant
What is Rac Mira Leiwant email address?
Rac Mira Leiwant's primary email address is ********@anika.com. To view the full verified email and additional contact details, sign up for free with Muraena.
What company does Rac Mira Leiwant work for?
Rac Mira Leiwant is a Vice President Regulatory Affairs, Clinical Affairs and Quality Assurance at Anika, a company specializing in Measuring & controlling devices, nec.
Where Rac Mira Leiwant graduated from?
Rac Mira Leiwant holds a degree in Mechanical Engineering/Bioengineering from Cornell University.
How can I directly contact Rac Mira Leiwant?
To contact Rac Mira Leiwant directly, you can use the email address ********@anika.com. Complete contact information is available upon registration with Muraena.
Who is Rac Mira Leiwant?
Rac Mira Leiwant is an accomplished Vice President with extensive expertise in regulatory affairs, clinical affairs, and quality assurance within the pharmaceutical and medical device industries. With a strong educational background in Mechanical Engineering and Bioengineering from Cornell University, Rac has successfully led teams in developing and implementing regulatory strategies for complex Class II and III products across global markets. They have a proven track record of managing cross-functional teams and ensuring compliance with rigorous standards such as ISO 13485 and FDA regulations. Rac's leadership experience spans various organizations, where they have been instrumental in driving product development and quality initiatives. Their strategic insights have significantly contributed to the successful launch of numerous medical devices and drug/device combination products. Additionally, Rac is known for their ability to navigate complex regulatory landscapes, making them a valuable asset in any organization aiming for innovation and compliance in healthcare.
Rac`s contact details
********@anika.com
********@anikatherapeutics.com
Colleagues
Vice President, US Sales
Advisor (Former CFO)
Executive Director National Accounts and Sales Operations
Executive Director, Clinical Affairs
Vice President, Commercial and Corporate Development
VP, Research & Development
Executive Director of US and Global Marketing
Chief Human Resources Officer
Vice President, Information Technology
Executive Director of Operations