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Heather H. Email & Phone Number

Post Market Surveillance | PSURs, PMS Reports & Plans | Remediation | Complaints & MDRs | EU-MDR | ISO 13485 at Eliassen Group
Location: Hoffman Estates, Illinois, United States 6 work roles 1 school
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Current company
Role
Post Market Surveillance | PSURs, PMS Reports & Plans | Remediation | Complaints & MDRs | EU-MDR | ISO 13485
Location
Hoffman Estates, Illinois, United States
Company size

Who is Heather H.? Overview

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Quick answer

Heather H. is listed as Post Market Surveillance | PSURs, PMS Reports & Plans | Remediation | Complaints & MDRs | EU-MDR | ISO 13485 at Eliassen Group, a company with 809 employees, based in Hoffman Estates, Illinois, United States. AeroLeads shows a matched LinkedIn profile for Heather H..

Heather H. previously worked as PSUR writer at Eliassen Group and Post Market Surveillance Specialist at Smith & Nephew. Heather H. holds Bachelor Of Applied Science (B.A.Sc.), Biology/Biological Sciences, General from University Of Wisconsin-Parkside.

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Eliassen Group

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About Heather H.

Heather H. is a Post Market Surveillance | PSURs, PMS Reports & Plans | Remediation | Complaints & MDRs | EU-MDR | ISO 13485 at Eliassen Group.

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Heather H.'s current company

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Eliassen Group
Eliassen Group
Post Market Surveillance | PSURs, PMS Reports & Plans | Remediation | Complaints & MDRs | EU-MDR | ISO 13485
reading, massachusetts, united states
Website
Employees
809
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6 roles

Heather H. work experience

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Psur Writer

Current

Remote

PSURs and related technical documentation for medical device company through Eliassen Group.

Feb 2024 - Present

Post Market Surveillance Specialist

Greater Chicago Area

Post Market Surveillance specialist involved in creation and maintenance of Post Market Surveillance reports, PSURs (Periodic Safety Update Reports), and PMS plans for class I-III medical devices, with a focus in orthopedics and trauma implants and instruments. Also involved in: PRER (PMS data for China NMPA), NPD, tracking and trending of complaints.

Feb 2016 - Dec 2023

Post Market Surveillance Specialist

Greater Memphis Area

Post Market Surveillance analyst in charge of creation and maintenance of Post Market Surveillance files for medical devices at Smith & Nephew.

Jun 2015 - Feb 2016

Quality And Compliance Consultant

Maetrics, Llc

West Palm Beach, Florida Area

Completion of a remediation project on complaints spanning two years. SAP system usage.

Apr 2013 - Dec 2014

Product Surveillance Quality Analyst

Completed a retrospective review of a product as per FDA guidelines. Coding current complaints and assuring current guidelines are up to date. Completing and checking MDRs and remedial action exemption coding. Opening and closing complaints. Updating complaints with AE actions and information. Knowledge of 21 CFR Part 820 - Medical Device reporting..

Oct 2010 - Apr 2013

Volunteer Researcher

National Center For Limb Preservation

Compiled patient chart data in relation to ongoing studies at the podiatry clinic. Investigated new methods of wound care treatment and supporting information for same. Represented the clinic at the Advocate Dimensions of Excellence conference in 2008.

Feb 2007 - Aug 2008
Team & coworkers

Colleagues at Eliassen Group

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1 education record

Heather H. education

FAQ

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What company does Heather H. work for?

Heather H. works for Eliassen Group.

What is Heather H.'s role at Eliassen Group?

Heather H. is listed as Post Market Surveillance | PSURs, PMS Reports & Plans | Remediation | Complaints & MDRs | EU-MDR | ISO 13485 at Eliassen Group.

Where is Heather H. based?

Heather H. is based in Hoffman Estates, Illinois, United States while working with Eliassen Group.

What companies has Heather H. worked for?

Heather H. has worked for Eliassen Group, Smith & Nephew, Maetrics, Llc, Baxter Healthcare, and National Center For Limb Preservation.

Who are Heather H.'s colleagues at Eliassen Group?

Heather H.'s colleagues at Eliassen Group include Cesar Yohari Mascaya, Chase Murray, Anushka A, Sandy Shafer, and Rebecca Smith.

How can I contact Heather H.?

You can use AeroLeads to view verified contact signals for Heather H. at Eliassen Group, including work email, phone, and LinkedIn data when available.

What schools did Heather H. attend?

Heather H. holds Bachelor Of Applied Science (B.A.Sc.), Biology/Biological Sciences, General from University Of Wisconsin-Parkside.

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