Richard Hines

Richard Hines Email and Phone Number

Senior Manager of Regulatory Affairs @ ImpediMed
Richard Hines's Location
Escondido, California, United States, United States
Richard Hines's Contact Details

Richard Hines personal email

n/a
About Richard Hines

Richard Hines is a Senior Manager of Regulatory Affairs at ImpediMed. He possess expertise in quality system, auditing, reviews, project management, isis and 8 more skills. Colleagues describe him as "Richard was a pleasure to work with. He was very reliable to complete projects in a timely-manner, always came to meetings well-prepared, provided insightful advice and was knowledge about the subject matter, and was very thorough in his work. His attitude was always upbeat and he is already sorely missed on our team!"

Richard Hines's Current Company Details
ImpediMed

Impedimed

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Senior Manager of Regulatory Affairs
Richard Hines Work Experience Details
  • Impedimed
    Senior Manager Of Regulatory Affairs
    Impedimed Aug 2022 - Present
    Carlsbad, Ca, Us
  • Zest Dental Solutions
    Manager Regulatory Affairs
    Zest Dental Solutions Oct 2021 - Present
    Carlsbad, Ca, Us
    *Regulatory strategy - New Product Development*510(k) Submissions*EU MDR Technical File Remediation*K220252
  • Pfm Medical, Inc.
    Senior Manager Regulatory Affairs
    Pfm Medical, Inc. Mar 2021 - Oct 2021
    Manage all regulatory tasks USA, Canada*Regulatory strategy - New Product Development*510(k) Submissions*Health Canada*PMA Annual Report Submission*FDA Correspondence
  • Biofilm Inc.
    Regulatory Affairs Manager
    Biofilm Inc. Oct 2014 - Mar 2021
    *USA and International Regulatory Submissions, including 510(K), FDA Pre-sub meetings*Medical Device global regulatory strategy*Class IIb Technical Files*Develop, Update, and Manage Design Control Process, DHFs, Design Reviews*Managing RA Compliance Program - including UDI, FDA Registrations, organic certification*Design Project Management - meeting scheduling, Project MGMT Software, deadlines, launch*OTC Drug Registrations*Develop Organic System and OSP, annual organic audit, organic 510(K) Cleared device*K163395, K171985, K200114, 200239
  • Volcano Corporation
    Regulatory Affairs Specialist
    Volcano Corporation Apr 2010 - Oct 2014
    San Diego, Ca, Us
    *International Submissions - Asia, South America, Canada*Design Team Rep. & Regulatory Guidance*Control of approved products and parts through ERP & Change Control
  • Djo, Llc
    Regulatory Affairs Specialist
    Djo, Llc Feb 2009 - Apr 2010
    Dallas, Tx, Us
    *International Submissions - Asia, South America, Canada*Design Team Rep. & Regulatory Guidance
  • Alphatec Spine
    Regulatory Affairs Associate
    Alphatec Spine Jun 2007 - Dec 2008
    Carlsbad, California, Us
    *EU Technical File Drafting*International Submissions - Japan SHONINs*Design Team Rep. & Regulatory Guidance
  • Innovacon, Inc.
    Regulatory Affairs Associate
    Innovacon, Inc. 2006 - 2007
    Us
  • Abbott Vascular
    Qc Chemist
    Abbott Vascular 2006 - 2006
    Abbott Park, Illinois, Us
  • Guidant
    Qc Chemist
    Guidant 2006 - 2006
  • Irvine Analytical Labs
    Qc Chemist
    Irvine Analytical Labs 2004 - 2006
  • Isis Pharmaceuticals
    Qc Chemist
    Isis Pharmaceuticals 2002 - 2005
    Carlsbad, Ca, Us

Richard Hines Skills

Quality System Auditing Reviews Project Management Isis Good Manufacturing Practice Regulatory Affairs Standard Operating Procedure Iso 14971 Fda Gmp Strategy Qc Biotechnology Industry

Richard Hines Education Details

  • San Diego City College
    San Diego City College

Frequently Asked Questions about Richard Hines

What company does Richard Hines work for?

Richard Hines works for Impedimed

What is Richard Hines's role at the current company?

Richard Hines's current role is Senior Manager of Regulatory Affairs.

What is Richard Hines's email address?

Richard Hines's email address is ri****@****ilm.com

What schools did Richard Hines attend?

Richard Hines attended San Diego City College.

What skills is Richard Hines known for?

Richard Hines has skills like Quality System, Auditing, Reviews, Project Management, Isis, Good Manufacturing Practice, Regulatory Affairs, Standard Operating Procedure, Iso 14971, Fda Gmp, Strategy, Qc.

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