Angela Frederickson

Angela Frederickson Email and Phone Number

Global MedTech RAQA Leader | Entrepreneurial Consultant | Regulatory Aficionado | Culture Creator | Compliance Reimagined @ Sparq Compliance
Angela Frederickson's Location
San Jose, California, United States, United States
Angela Frederickson's Contact Details

Angela Frederickson work email

Angela Frederickson personal email

About Angela Frederickson

High performing Quality and Regulatory Affairs leader with 20+ years of experience in the domestic and international Medical Device space. Proven track record of effectively developing and implementing regulatory strategies and Quality Management Systems in start-up, mid-size, and multi-national organizations. Demonstrated success in negotiations with FDA and Global Regulatory Authorities resulting in mutually beneficial partnerships. Adept at people leadership and culture building across functional groups with a successful track record of culture transformation. Recognized for exemplary leadership, communication, and attracting and developing regulatory talent.

Angela Frederickson's Current Company Details
Sparq Compliance

Sparq Compliance

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Global MedTech RAQA Leader | Entrepreneurial Consultant | Regulatory Aficionado | Culture Creator | Compliance Reimagined
Angela Frederickson Work Experience Details
  • Sparq Compliance
    Founder And Principal Raqa Consultant
    Sparq Compliance May 2021 - Present
    California, United States
  • Align Technology
    Director, Government Affairs, Regulatory Affairs, Quality - Americas
    Align Technology Jul 2018 - May 2021
    San Jose
  • Outset Medical, Inc.
    Director Raqa
    Outset Medical, Inc. Jul 2017 - Jul 2018
  • Outset Medical, Inc.
    Associate Director Regulatory Affairs
    Outset Medical, Inc. Jul 2016 - Jun 2017
  • Outset Medical, Inc.
    Sr. Manager Regulatory Affairs
    Outset Medical, Inc. May 2015 - Jul 2016
    San Jose, California
  • Fisher & Paykel Healthcare
    Product Groups Regulatory Affairs Manager
    Fisher & Paykel Healthcare Dec 2013 - Apr 2015
    Auckland, New Zealand
    Managing the Regulatory Teams within OSA (Obstructive Sleep Apnea) and RAC (Respiratory Acute Care)Fisher & Paykel entered the respiratory care market in 1971 with the development of a uniquerespiratory humidifier system for use in critical care. We now offer a broad range of products andsystems for use in respiratory and acute care and the treatment of obstructive sleep apnea.SpecialtiesObstructive Sleep Apnea (OSA), Neonatal, Respiratory Humidification, Surgical HumidificationINTERNATIONAL REACH...Our headquarters and research facilities are based in New Zealand,with manufacturing facilities located in New Zealand and Mexico. In total, our products are sold inmore than 120 countries either directly by our offices or through distributors and OEMs. We supportour customers with sales and marketing operations located in 30 countries.
  • Accessclosure, Inc.
    Manager, Regulatory Affairs
    Accessclosure, Inc. Feb 2012 - Oct 2013
    Mountain View, Ca
  • Accessclosure, Inc.
    Sr. Compliance Specialist/Regulatory Affairs Specialist
    Accessclosure, Inc. Aug 2006 - Mar 2012
  • Accessclosure
    Sr. Compliance Engineer
    Accessclosure Aug 2006 - Nov 2010
  • Lumenis
    Quality Engineer
    Lumenis Oct 2004 - Aug 2006
  • Volcano Corporation
    Quality Engineer
    Volcano Corporation 1998 - 2004

Angela Frederickson Skills

Fda Quality System Iso 13485 Medical Devices Capa Regulatory Affairs Quality Auditing Quality Assurance 21 Cfr Part 11 Design Control 21 Cfr V&v Validation Cross Functional Team Leadership Iso 9000 Pma Iso 14971 Gmp Process Improvement Compliance Quality Systems Iso Catheters Product Development Sop R&d Change Control Medical Device Directive Fmea Ce Marking

Angela Frederickson Education Details

  • San Jose State University
    San Jose State University
    Asian Studies

Frequently Asked Questions about Angela Frederickson

What company does Angela Frederickson work for?

Angela Frederickson works for Sparq Compliance

What is Angela Frederickson's role at the current company?

Angela Frederickson's current role is Global MedTech RAQA Leader | Entrepreneurial Consultant | Regulatory Aficionado | Culture Creator | Compliance Reimagined.

What is Angela Frederickson's email address?

Angela Frederickson's email address is ab****@****ail.com

What schools did Angela Frederickson attend?

Angela Frederickson attended San Jose State University.

What skills is Angela Frederickson known for?

Angela Frederickson has skills like Fda, Quality System, Iso 13485, Medical Devices, Capa, Regulatory Affairs, Quality Auditing, Quality Assurance, 21 Cfr Part 11, Design Control, 21 Cfr, V&v.

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