Denise Curtis

Denise Curtis Email and Phone Number

Analyst II, Global MDR Submissions @ Olympus Corporation of the Americas
center valley, pennsylvania, united states
Denise Curtis's Location
Dunlap, Tennessee, United States, United States
Denise Curtis's Contact Details
About Denise Curtis

Senior Post Market Surveillance Specialist with over 25 years experience - Medical Device Manufacturing. Knowledgeable in a wide variety of Class I, Class II, and Class III medical devices. Adept in the area of adverse event reporting, CAPA process, risk analysis, with proven competency in the FDA Quality System, Medical Device Reporting Regulations (21 CFR 803 and 21 CFR 820), ISO 13485:2016, and EU MDR 2017:745.

Denise Curtis's Current Company Details
Olympus Corporation of the Americas

Olympus Corporation Of The Americas

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Analyst II, Global MDR Submissions
center valley, pennsylvania, united states
Employees:
4190
Denise Curtis Work Experience Details
  • Olympus Corporation Of The Americas
    Analyst Ii, Global Mdr Submissions
    Olympus Corporation Of The Americas Oct 2024 - Present
  • Eliquent Life Sciences
    Analyst Ii, Global Mdr Submissions - Olympus
    Eliquent Life Sciences Aug 2023 - Oct 2024
    United States
  • Propharma Group
    Complaint Handler - Risk Management
    Propharma Group May 2022 - Feb 2023
    Remote
  • Enhanced Compliance, Inc.
    Senior Post Market Surveillance
    Enhanced Compliance, Inc. Feb 2022 - May 2022
    Remote
    Remediation of complaint files per FDA 483’s.
  • Eg Life Sciences
    Product Quality Specialist
    Eg Life Sciences May 2021 - Jun 2021
    Remote
    Remediation project - Complete
  • Treximo
    Consultant - Regulatory Reporting Coordinator
    Treximo Jul 2017 - Sep 2019
    Cook Medical, Bloomington, Indiana, United States
  • Conmed Corporation
    Medical Device Reporting Specialist - Team Lead
    Conmed Corporation Dec 2014 - Jul 2017
    Largo, Florida, United States
  • Validant
    Sr Post Market Surveillance Specialist
    Validant Jul 2013 - Aug 2014
    Fresenius Medical Care - Waltham, Ma
  • Maetrics
    Sr. Compliance & Quality Consultant
    Maetrics Aug 2012 - Jun 2013
    Depuy Orthopaedics, Warsaw, In
  • Oxford Global Resources
    Consultant - Post Market Surveillance
    Oxford Global Resources Apr 2012 - Jul 2012
    Stryker Spine - Allendale, Nj
  • Black Diamond Networks - Stryker Medical
    Sr Regulatory Affairs Representative - Post Market Surveillance
    Black Diamond Networks - Stryker Medical Jun 2010 - Dec 2011
    Kalamazoo, Michigan Area
  • Validant
    Sr. Post Market Surveillance Specialist
    Validant Apr 2010 - Jun 2010
    Medtronic Crdm, Minneapolis, Mn
  • Validant - Boston Scientific Corporation
    Sr. Post Market Surveillance Specialist
    Validant - Boston Scientific Corporation Aug 2008 - Dec 2009
    Marlborough, Massachusetts, United States
  • Conmed Corporation
    Medical Device Reporting Specialist
    Conmed Corporation May 2007 - Jul 2008
  • Intellect Technical Solutions - Baxter Healthcare
    Product Surveillance Specialist Ii - Consultant
    Intellect Technical Solutions - Baxter Healthcare Nov 2005 - Dec 2006
    Largo, Florida, United States
  • Bovie Medical
    Documentation Department Supervisor / Complaints Administrator
    Bovie Medical Jun 2000 - Jan 2005
    Largo, Florida, United States
  • Raytron Enterprises Inc. Of Florida
    Warehouse Manager
    Raytron Enterprises Inc. Of Florida Oct 1992 - Dec 1999
  • Mindis Recycling
    Office Manager
    Mindis Recycling Sep 1989 - Mar 1992
  • Raytron Enterprises Inc. Of Florida
    Office Manager/Warehouse Operations
    Raytron Enterprises Inc. Of Florida Oct 1987 - May 1989

Denise Curtis Skills

Word Outlook Jd Edwards Great Plains Software Medical Devices Compliance Mentoring Complaint Handling Documentation Customer Relations Risk Management Inventory Management Access Problem Solving Quality Systems Capa Budgeting Excel Lotus Notes Pagemaker Microsoft Office Purchasing Negotiation Change Management Iso 13485 Trackwise Activity Expert And Reporting Medical Device Adverse Event Reporting Regulatory Affairs Quality Assurance Risk Assessment Complaint Management Quality System Customer Service Fda Software Documentation Gmp Quality Auditing Validation Change Control Root Cause Analysis Training 21 Cfr Part 11 Microsoft Word Microsoft Excel Budgets Sop U.s. Food And Drug Administration Corrective And Preventive Action

Frequently Asked Questions about Denise Curtis

What company does Denise Curtis work for?

Denise Curtis works for Olympus Corporation Of The Americas

What is Denise Curtis's role at the current company?

Denise Curtis's current role is Analyst II, Global MDR Submissions.

What is Denise Curtis's email address?

Denise Curtis's email address is de****@****med.com

What is Denise Curtis's direct phone number?

Denise Curtis's direct phone number is +193122*****

What skills is Denise Curtis known for?

Denise Curtis has skills like Word, Outlook, Jd Edwards, Great Plains Software, Medical Devices, Compliance, Mentoring, Complaint Handling, Documentation, Customer Relations, Risk Management, Inventory Management.

Who are Denise Curtis's colleagues?

Denise Curtis's colleagues are Olga Ponkratova, Carmel Bolton, Nicolae Marinescu, Leslie Hughes, Kunihiro Idei, Eleni Araya, Nelly Adriao.

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