Jon Lang

Jon Lang Email and Phone Number

Dir. Regulatory Affairs-Patient Interface and Software @ Philips
Boston, MA, US
Jon Lang's Location
Greater Boston, United States
About Jon Lang

Jon Lang is a Dir. Regulatory Affairs-Patient Interface and Software at Philips. Colleagues describe him as "I have known and worked for Jon for 6 years. Jon is a knowledgeable regulatory professional and willing to jump in and help others as needed. He is willing to work long hours to meet deadlines to get the job done. Jon has had successful dealings with the FDA in the ever changing field of extractables and leachables with regards to ISO 10993-17. Jon will be a great asset to any tram."

Jon Lang's Current Company Details
Philips

Philips

View
Dir. Regulatory Affairs-Patient Interface and Software
Boston, MA, US
Website:
philips.com
Employees:
70504
Jon Lang Work Experience Details
  • Philips
    Dir. Regulatory Affairs-Patient Interface And Software
    Philips
    Boston, Ma, Us
  • Philips
    Dir. Regulatory Affairs-Patient Interface & Software
    Philips Jul 2023 - Present
    Cambridge, Massachusetts, United States
  • Fresenius Medical Care North America
    Dir. Regulatory Affairs - Devices
    Fresenius Medical Care North America 2017 - 2023
    Waltham, Ma
  • Fresenius Medical Care North America
    Sr. Regulatory Affairs Manager - Devices
    Fresenius Medical Care North America 2016 - 2017
    Waltham, Ma
  • Fresenius Medical Care North America
    Regulatory Affairs Manager – Devices
    Fresenius Medical Care North America 2012 - 2016
    Waltham, Ma
  • Fresenius Medical Care
    Regulatory Affairs Specialist
    Fresenius Medical Care 2010 - 2012
    Waltham, Ma
    Perform regulatory assessments and develop regulatory strategies for new devices or modifications to existing devices. Provide proactive guidance to project teams with a concise description of deliverables required for a successful submission. Critically review of all submission-related documents and provide constructive, balanced feedback to raise the quality of the submission and clarity of the submission ‘story’. Author Pre-Submissions and 510(k)s.
  • Bionostics
    Manufacturing Engineering Supervisor
    Bionostics 2007 - 2009
    Responsible for the transition of new products from R & D to manufacturing through to commercial launch, e.g., scale-up, process development, validation, production documents, package design, etc.
  • Bionostics
    Manufacturing Group Leader
    Bionostics 1999 - 2007
    Supervised activities of the Formulation and Filling Department ensuring operations were consistent with established procedures, customer requirements and cGMP guidelines. Responsible for formulation, processing and filling of blood gas, co-oximetry and bottled in-vitro diagnostic controls.
  • Chiron/Bayer Diagnostics
    Manufacturing Quality Control And Mixing Specialist
    Chiron/Bayer Diagnostics 1997 - 1999
    Medfield, Ma
    Member of Quality Control department supporting the formulation and filling departments using a wide range of analytical techniques and equipment. Formulated reagents and blood gas controls used for Ciba-Corning, Chiron and Bayer point of care and clinical diagnostic analyzers.

Jon Lang Education Details

  • North Adams State
    North Adams State
    Biology
  • University Of Western Sydney, Australia
    University Of Western Sydney, Australia
    Biology
  • Worcester Polytechnical Institute (Wpi)
    Worcester Polytechnical Institute (Wpi)
    Medical Device Certificate Program– Regulatory Affairs
  • Wayland High School
    Wayland High School
    High School

Frequently Asked Questions about Jon Lang

What company does Jon Lang work for?

Jon Lang works for Philips

What is Jon Lang's role at the current company?

Jon Lang's current role is Dir. Regulatory Affairs-Patient Interface and Software.

What schools did Jon Lang attend?

Jon Lang attended North Adams State, University Of Western Sydney, Australia, Worcester Polytechnical Institute (Wpi), Wayland High School.

Who are Jon Lang's colleagues?

Jon Lang's colleagues are Allison Jones, Margherita E. Genet, Tejas Shah, Oleksandr Patsahan, Dennis Beecher, Bob Levine, Michael Moorhead.

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