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Elaine Taine Email & Phone Number
Advisor, IVD Regulatory Affairs
at
Helical Sphere
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✓ Verified July 2026
3 data sources
Profile completeness 86%
Current company
Role
Advisor, IVD Regulatory Affairs
Location
Columbia, South Carolina, United States
Company size
Who is Elaine Taine? Overview
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Quick answer
Elaine Taine is listed as Advisor, IVD Regulatory Affairs at Helical Sphere, a with 2 employees, based in Columbia, South Carolina, United States. AeroLeads shows a matched LinkedIn profile for Elaine Taine.
Elaine Taine previously worked as IVD RA Advisor at Helical Sphere and Sr. IVDR Consultant at Thermo Fisher Scientific. Elaine Taine holds Postdoctoral Training, Molecular Physiology from University Of California, Los Angeles.
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Helical Sphere
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Profile bio
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
Current workplace
Elaine Taine's current company
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Helical Sphere
7 roles
Elaine Taine work experience
A career timeline built from the work history available for this profile.
Ivd Ra Advisor
CurrentAdvise on in vitro diagnostic device (IVD) US 510(k) clearance and EU IVDR CE mark, and ISO13485:2016 & 21CFR820 QMS establishment, improvement and audits
Sep 2019 - Present
Sr. Ivdr Consultant
Responsible for documenting clinical evidence per IVDR and supporting compilation of technical documentation
Jul 2020 - Mar 2022
Managing Director
Hob Biotech Group Usa
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
Aug 2015 - Aug 2019
Manager, Research And Development
Responsible for IVD product development, clinical study, 510(k) clearance & CE mark, ISO 13485/QSR820 compliance, project and people management
Dec 2011 - Jul 2015
Senior Scientist
Responsible for IVD product development and project management
Dec 2010 - Nov 2011
Scientist I
Responsible for current product improvement, assay validation, 510(k) preparation
Mar 2010 - Nov 2010
4 education records
Elaine Taine education
Postdoctoral Training, Molecular Physiology
University Of California, Los Angeles
Ph.D., Neurobiology
University Of Maryland, Baltimore (Umb)
M.S., Biochemistry And Molecular Biology
Central South University
B.M. (M.D. Us Equiv.), Clinical Medicine
Central South University
FAQ
Frequently asked questions about Elaine Taine
Quick answers generated from the profile data available on this page.
What company does Elaine Taine work for?
Elaine Taine works for Helical Sphere.
What is Elaine Taine's role at Helical Sphere?
Elaine Taine is listed as Advisor, IVD Regulatory Affairs at Helical Sphere.
Where is Elaine Taine based?
Elaine Taine is based in Columbia, South Carolina, United States while working with Helical Sphere.
What companies has Elaine Taine worked for?
Elaine Taine has worked for Helical Sphere, Thermo Fisher Scientific, Hob Biotech Group Usa, and Hycor Biomedical, Inc..
How can I contact Elaine Taine?
You can use AeroLeads to view verified contact signals for Elaine Taine at Helical Sphere, including work email, phone, and LinkedIn data when available.
What schools did Elaine Taine attend?
Elaine Taine holds Postdoctoral Training, Molecular Physiology from University Of California, Los Angeles.
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