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Rac Mira Leiwant

Rac Mira Leiwant

Vice President Regulatory Affairs, Clinical Affairs and Quality Assurance | Anika

Boston, Massachusetts, United States

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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.

General

Specialist

Technical Background

Leadership Experience

Long-Term Tenure

Professional interests

Emerging Technologies

Leadership Development

Sustainability

Organisational experience

Corporate Experience

Rac Mira Leiwant

Work Experience

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Vice President Regulatory Affairs, Clinical Affairs and Quality Assurance at

Anika

November 2019 - Present

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Vice President, Regulatory Affairs at

Boston Scientific

November 2016 - November 2019

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Senior Director, Quality Engineering and Regulatory Affairs at

Acelity

March 2013 - November 2016

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Director, Quality Engineering at

Lifecell Hair Restoration

March 2013 - April 2014

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Director, Quality Assurance at

Svelte Medical Systems, Inc.

March 2011 - March 2013

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Director of Quality Assurance at

Vascular Therapies

March 2009 - February 2011

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Consultant at

Micell Technologies, Inc.

January 2010 - January 2011

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Product Director, Global Strategic Marketing at

Johnson & Johnson

January 2008 - December 2008

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Manager Health Care Compliance at

Cordis

September 2007 - December 2007

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Quality Assurance Manager, Promotional Review at

Cordis

October 2005 - August 2007

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Manager, Quality Assurance at

Cordis

March 2003 - October 2005

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Sr. Quality Engineer, New Product Development at

Cordis

June 2001 - March 2003

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New Product Development Engineer at

Cordis A Johnson And Johnson

January 1998 - January 2001

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College Intern at

Muro Pharmaceuticals

January 1994 - January 1997

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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

mail

********@anika.com

********@anikatherapeutics.com

Colleagues

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Ben Joseph

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Dawn Wilson

VP, Research & Development

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Kevin Statz

Executive Director of US and Global Marketing

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Tom Finnerty

Chief Human Resources Officer

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Brian Horne

Vice President, Information Technology

George Lakomy

Executive Director of Operations

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