Taras Bouzakine

Taras Bouzakine Email and Phone Number

Director, Global Regulatory Affairs @ AngioSafe, Inc.
St. Augustine, FL, US
Taras Bouzakine's Location
St Augustine, Florida, United States, United States
Taras Bouzakine's Contact Details
About Taras Bouzakine

Regulatory affairs professional with over 15 years of strategic and tactical experience in U.S. (510(k), PMA, HDE, IDE), EU, and international approvals, post-market submissions, regulatory intelligence, reviewer negotiations, and strategic planning for medical devices. Enthusiastic team leader and player with a strong aspiration for success.Experienced in working with multinational and start-up medical device companies, including Boston Scientific, Johnson & Johnson, Olympus, Philips, Genzyme, Abiomed, and others.

Taras Bouzakine's Current Company Details
AngioSafe, Inc.

Angiosafe, Inc.

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Director, Global Regulatory Affairs
St. Augustine, FL, US
Website:
angiosafe.com
Employees:
27
Taras Bouzakine Work Experience Details
  • Angiosafe, Inc.
    Director, Global Regulatory Affairs
    Angiosafe, Inc.
    St. Augustine, Fl, Us
    View
  • Veranex
    Director, Regulatory Affairs
    Veranex Jan 2022 - Present
    Raleigh, North Carolina, Us
    View
  • Experien Group
    Director, Regulatory Affairs
    Experien Group Feb 2021 - Dec 2021
    San Jose, Ca, Us
    View
  • Adhesys Medical
    Global Director Of Regulatory Affairs
    Adhesys Medical Jul 2016 - Feb 2021
    Regulatory head for the company. Lead all U.S. and European RA efforts for Class 2 and Class 3 devices. Obtained multiple FDA Breakthrough device designations. Developed and negotiated pre-clinical and clinical testing strategies. Managed multiple external consultants. Reported to the company co-founder.
  • Abiomed
    Regulatory Affairs Manager
    Abiomed Feb 2013 - Jul 2016
    Danvers, Ma, Us
    Lead a PMA Module submission and supported an original PMA approval for a Class 3 device. Lead a Panel-Track PMA supplement submission. Supported original approval in Japan. Implemented an internal regulatory compliance training program. Mentored new RA team members. Reported to the SVP.
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  • Tagabonds
    Traveler
    Tagabonds May 2012 - Nov 2012
    Traveled around the US by car, visited all 50 states.
  • Genzyme
    Principal Associate, Regulatory Affairs
    Genzyme Jan 2010 - Apr 2012
    Paris, France, Fr
    Supported Class 3 and Class 2 products in the U.S., Asia-Pacific, EU, and other international markets. Authored new submissions, CMC change supplements, and labeling updates. Managed a staff on product registration and process improvement projects. Promoted from International to Product RA position.
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  • Clinivation, Inc.
    Director, Market Clearance Solutions
    Clinivation, Inc. Jun 2005 - Jan 2010
    Us
    Managed a team to achieve consulting project milestones, including U.S. and international registrations, market prioritization, and regulatory intelligence analysis. Reported to the company VP.
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Taras Bouzakine Skills

Medical Devices Regulatory Affairs Fda Regulatory Submissions Capa Iso 13485 Pma Validation Gmp Regulatory Requirements Quality System Cmc Clinical Trials Premarket Approval

Taras Bouzakine Education Details

  • Worcester Polytechnic Institute
    Worcester Polytechnic Institute
    Biomedical Engineering

Frequently Asked Questions about Taras Bouzakine

What company does Taras Bouzakine work for?

Taras Bouzakine works for Angiosafe, Inc.

What is Taras Bouzakine's role at the current company?

Taras Bouzakine's current role is Director, Global Regulatory Affairs.

What is Taras Bouzakine's email address?

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What is Taras Bouzakine's direct phone number?

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What schools did Taras Bouzakine attend?

Taras Bouzakine attended Worcester Polytechnic Institute.

What skills is Taras Bouzakine known for?

Taras Bouzakine has skills like Medical Devices, Regulatory Affairs, Fda, Regulatory Submissions, Capa, Iso 13485, Pma, Validation, Gmp, Regulatory Requirements, Quality System, Cmc.

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