Don Guthner

Don Guthner Email and Phone Number

Regulatory Affairs Consultant @ Maxx Orthopedics Inc.
Douglassville, PA, US
Don Guthner's Location
Douglassville, Pennsylvania, United States, United States
Don Guthner's Contact Details

Don Guthner personal email

n/a

Don Guthner phone numbers

About Don Guthner

Strong background in Class II & III Medical Device submissions. Innovative Regulatory strategies, Clinical Trial Management, FDA and EU MDR compliance.Specialties: Orthopaedics, Ophthalmology, OB-GYN, Anti-adhesion, Osteoporosis, Osteoarthritis, Electrical Stimulation, Medical Lasers, Neurology/Psychiatry

Don Guthner's Current Company Details
Maxx Orthopedics Inc.

Maxx Orthopedics Inc.

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Regulatory Affairs Consultant
Douglassville, PA, US
Website:
maxxortho.com
Employees:
83
Don Guthner Work Experience Details
  • Maxx Orthopedics Inc.
    Regulatory Affairs Consultant
    Maxx Orthopedics Inc.
    Douglassville, Pa, Us
    View
  • Maxx Orthopedics Inc.
    Director Of Regulatory Affairs
    Maxx Orthopedics Inc. Jun 2024 - Present
    King Of Prussia, Pennsylvania, United States
    View
  • Kapstone Medical
    Regulatory Affairs Specialist
    Kapstone Medical May 2021 - Jun 2024
    Greater Philadelphia
    View
  • Camber Spine
    Regulatory Affairs Manager
    Camber Spine Mar 2020 - May 2021
    King Of Prussia, Pennsylvania, United States
    Moved from FT position of Manager, Regulatory Affairs to Contractor in May 2021
    View
  • Seeking A New Opportunity
    Global Regulatory Affairs Management Medical Devices
    Seeking A New Opportunity Feb 2020 - Mar 2020
    View
  • Neuronetics, Inc.
    Regulatory Affairs Manager
    Neuronetics, Inc. Jan 2019 - Feb 2020
    Malvern, Pa
    Tasked with preparing the company to meet the requirements of the new EU MDR requirements; maintain current OUS product licenses; notify Staff of changes to relevant US and OUS regulations; prepare US/OUS regulatory submissions and reports; review/approve Labeling and Design Changes; other projects as assigned.
    View
  • Orgenix, Llc
    Principal/Owner
    Orgenix, Llc Mar 2007 - Dec 2018
    Douglassville, Pa
    A Regulatory and Clinical Research Management Organization specializing in meeting the needs of US and OUS small to medium-sized Medical Device companies. I managed all facets of administration, including marketing, staff, budgets, proposals and business plans
  • Orca, Llc
    Principal
    Orca, Llc Nov 2004 - May 2006
    Regulatory Consultant, Clinical Trial Management
  • Mcra, Llc
    Vice President And Founder
    Mcra, Llc Jan 2001 - Jan 2004
  • Iolab
    Group Leader/Sr. Cra
    Iolab 1983 - 1990

Don Guthner Skills

Medical Devices Clinical Trials Fda Orthopedic Market Development Spine Regulatory Affairs Clinical Research Iso 13485 Capital Equipment Orthopedics New Business Development Hardware Diagnostics Design Control Surgery Biotechnology Healthcare Lifesciences U.s. Food And Drug Administration Management Product Development Recruiting

Don Guthner Education Details

Frequently Asked Questions about Don Guthner

What company does Don Guthner work for?

Don Guthner works for Maxx Orthopedics Inc.

What is Don Guthner's role at the current company?

Don Guthner's current role is Regulatory Affairs Consultant.

What is Don Guthner's email address?

Don Guthner's email address is dg****@****tar.com

What is Don Guthner's direct phone number?

Don Guthner's direct phone number is +164646*****

What schools did Don Guthner attend?

Don Guthner attended The Julius Maximilians University Of Würzburg, Oregon State University.

What skills is Don Guthner known for?

Don Guthner has skills like Medical Devices, Clinical Trials, Fda, Orthopedic, Market Development, Spine, Regulatory Affairs, Clinical Research, Iso 13485, Capital Equipment, Orthopedics, New Business Development.

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