Donna Jacobs

Donna Jacobs Email and Phone Number

RETIRED @ Home Based in SC
Bluffton, SC, US
Donna Jacobs's Location
Bluffton, South Carolina, United States, United States
Donna Jacobs's Contact Details
About Donna Jacobs

Medical Device industry professional with 30+ years experience in clinical operations for Class II and III medical devices. IDE, PMA, 510k, CE Mark experience with significant risk implantable devices and non-significant risk devices in start-up, medium, and large company environments.Specialties: Ophthalmology, Orthopedics, Women's Health, Wound Closure, Urogynecology, Plastic & Reconstructive Surgery, Medical Aesthetics

Donna Jacobs's Current Company Details
Home Based in SC

Home Based In Sc

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RETIRED
Bluffton, SC, US
Donna Jacobs Work Experience Details
  • Home Based In Sc
    Retired
    Home Based In Sc
    Bluffton, Sc, Us
  • Abbvie
    Director, Clinical Trial Management
    Abbvie May 2020 - Present
    North Chicago, Illinois, Us
    Program Lead, Clinical Development Operations for global medical device clinical trials. Therapeutic areas include medical aesthetics and plastics & regenerative medicine.
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  • Allergan
    Director, Clinical Trial Management
    Allergan Feb 2017 - May 2020
    Dublin, Coolock, Ie
    Program Operations Lead for pre-market and post-approval clinical trials for medical devices. Therapeutic areas include regenerative medicine in breast reconstruction (tissue matrix), ophthalmology/dry eye (neurostimulation), and medical aesthetics (fillers).
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  • Lifecell, An Acelity Company
    Director, Clinical Operations
    Lifecell, An Acelity Company Sep 2012 - Feb 2017
    San Antonio, Tx, Us
    Planned and directed the execution of global clinical studies for acellular dermal matrices to support regulatory approvals and obtain desired claims and indications.
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  • Johnson & Johnson
    Manager, Clinical Operations
    Johnson & Johnson Nov 2007 - Sep 2012
    New Brunswick, Nj, Us
    Planned and executed early feasibility, feasibility and pivotal clinical trials in US and EU for an innovative neurostimulation device for Overactive Bladder/Urinary Incontinence, under a pilot internal venture program.
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  • Replication Medical Inc
    Director, Clinical Affairs
    Replication Medical Inc Jan 2006 - Jun 2007
    Planned and managed pilot/feasibility clinical trials in an innovative start-up spinal implant medical device company. Developed clinical department SOPs.
  • Johnson & Johnson
    Manager, Clinical Operations
    Johnson & Johnson May 2002 - Dec 2005
    New Brunswick, Nj, Us
    Managed post-market medical device clinical trials in Women's Health and established department operational initiatives.Previous positions: Clinical Project Manager, Sr. Clinical Project Manager
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  • Stryker
    Manager, Clinical Research
    Stryker Sep 1986 - May 2002
    Kalamazoo, Mi, Us
    Managed a clinical research department responsible for planning and executing Total Joint Replacement and Spinal Implant pre-market and post-market studies. IDE and PMA preparation.Previous positions: CRA, Sr. CRA, Regulatory Affairs Specialist
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  • Sharplan Lasers Inc
    Clinical Research Assistant
    Sharplan Lasers Inc Jan 1985 - Sep 1986
    Study manager, clinical data reviewer and report writer for an IDE study on a new ophthalmic laser. PMA preparation for FDA submission and Advisory Panel meeting.
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Donna Jacobs Skills

Tactical Planning Clinical Trials Clinical Research Clinical Monitoring Clinical Operations Department Budgeting Team Leadership Regulatory Submissions Medical Devices Gcp Fda Cross Functional Team Leadership Clinical Development People Development Project Management Ide Pma Succession Planning Vendor Management Research Ethics Global Clinical Studies Bimo Inspections 510k Protocol Development Crf Development Sops Clinical Quality Control Cro Oversight Contractor Management Contingent Workforce Neuromodulation Urogynecology Joint Replacement Osteoarthritis Ich Gcp Investigator Initiated Studies Edc Protocol Sop Crf Design Regulatory Affairs U.s. Food And Drug Administration Good Clinical Practice

Donna Jacobs Education Details

  • Ramapo College Of New Jersey
    Ramapo College Of New Jersey
    Business Administration - Management

Frequently Asked Questions about Donna Jacobs

What company does Donna Jacobs work for?

Donna Jacobs works for Home Based In Sc

What is Donna Jacobs's role at the current company?

Donna Jacobs's current role is RETIRED.

What is Donna Jacobs's email address?

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What is Donna Jacobs's direct phone number?

Donna Jacobs's direct phone number is .210.524*****

What schools did Donna Jacobs attend?

Donna Jacobs attended Ramapo College Of New Jersey.

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What skills is Donna Jacobs known for?

Donna Jacobs has skills like Tactical Planning, Clinical Trials, Clinical Research, Clinical Monitoring, Clinical Operations, Department Budgeting, Team Leadership, Regulatory Submissions, Medical Devices, Gcp, Fda, Cross Functional Team Leadership.

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