Elaine Taine

Elaine Taine Email and Phone Number

Advisor, IVD Regulatory Affairs @ Helical Sphere
United States
Elaine Taine's Location
Columbia, South Carolina, United States, United States
Elaine Taine's Contact Details

Elaine Taine personal email

About Elaine Taine

IVD RA professional experienced in,- RA: regulatory strategy and 510(k) submission; clinical evidence documentation and TD compilation per IVDR - QA: implement ISO13485- and 21CFR820-QMS and audit IVD developers/manufacturers & suppliers for compliance - R&D: IVD product development; software (including SaMD) development and documentation- Op: biotech startups with $MM initial funding; infrastructure building; business operation- Ppl: people hiring, training, managing, developing; DiSC profile; SMART goal setting & performance review, situational leadership, team building

Elaine Taine's Current Company Details
Helical Sphere

Helical Sphere

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Advisor, IVD Regulatory Affairs
United States
Website:
HelicalSphere.com
Employees:
2
Elaine Taine Work Experience Details
  • Helical Sphere
    Helical Sphere
    United States
    View
  • Helical Sphere
    Ivd Ra Advisor
    Helical Sphere Sep 2019 - Present
    Columbia, Sc, Us
    Advise on in vitro diagnostic device (IVD) US 510(k) clearance and EU IVDR CE mark, and ISO13485:2016 & 21CFR820 QMS establishment, improvement and audits
    View
  • Thermo Fisher Scientific
    Sr. Ivdr Consultant
    Thermo Fisher Scientific Jul 2020 - Mar 2022
    Waltham, Ma, Us
    Responsible for documenting clinical evidence per IVDR and supporting compilation of technical documentation
    View
  • Hob Biotech Group Usa
    Managing Director
    Hob Biotech Group Usa Aug 2015 - Aug 2019
    Primary responsibilities: establish and operate US companies; gather US/EU regulatory intelligence, lay out regulatory strategy and prepare submissions, FDA interfacing; QMS ISO13485/QSR820 integration, improvements & quality audits; product development; people management
  • Hycor Biomedical, Inc.
    Manager, Research And Development
    Hycor Biomedical, Inc. Dec 2011 - Jul 2015
    Garden Grove, California, Us
    Responsible for IVD product development, clinical study, 510(k) clearance & CE mark, ISO 13485/QSR820 compliance, project and people management
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  • Hycor Biomedical, Inc.
    Senior Scientist
    Hycor Biomedical, Inc. Dec 2010 - Nov 2011
    Garden Grove, California, Us
    Responsible for IVD product development and project management
    View
  • Hycor Biomedical, Inc.
    Scientist I
    Hycor Biomedical, Inc. Mar 2010 - Nov 2010
    Garden Grove, California, Us
    Responsible for current product improvement, assay validation, 510(k) preparation
    View

Elaine Taine Education Details

  • University Of California, Los Angeles
    University Of California, Los Angeles
    Molecular Physiology
  • University Of Maryland, Baltimore (Umb)
    University Of Maryland, Baltimore (Umb)
    Neurobiology
  • Central South University
    Central South University
    Biochemistry And Molecular Biology
  • Central South University
    Central South University
    Clinical Medicine

Frequently Asked Questions about Elaine Taine

What company does Elaine Taine work for?

Elaine Taine works for Helical Sphere

What is Elaine Taine's role at the current company?

Elaine Taine's current role is Advisor, IVD Regulatory Affairs.

What is Elaine Taine's email address?

Elaine Taine's email address is et****@****ail.com

What schools did Elaine Taine attend?

Elaine Taine attended University Of California, Los Angeles, University Of Maryland, Baltimore (Umb), Central South University, Central South University.

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