Chris Doherty

Chris Doherty Email and Phone Number

Sr. Lead GRA Software & Cybersecurity at Fresenius Medical Care @ Fresenius Medical Care
Wills Point, TX, US
Chris Doherty's Location
Wills Point, Texas, United States, United States
Chris Doherty's Contact Details

Chris Doherty personal email

n/a
About Chris Doherty

Life science professional with significant regulatory affairs experience designing and launching cutting edge medical devices, applications and drug products. Pursuing opportunities to leverage my skills and leadership into a senior level regulatory affairs consulting position.

Chris Doherty's Current Company Details
Fresenius Medical Care

Fresenius Medical Care

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Sr. Lead GRA Software & Cybersecurity at Fresenius Medical Care
Wills Point, TX, US
Website:
freseniusmedicalcare.com
Employees:
49625
Chris Doherty Work Experience Details
  • Fresenius Medical Care
    Fresenius Medical Care
    Wills Point, Tx, Us
    View
  • Fresenius Medical Care
    Senior Lead Global Regulatory Affairs - Software And Cybersecurity
    Fresenius Medical Care Apr 2023 - Present
    Bad Homburg, Frankfurt, De
    Global regulatory lead for all software and cybersecurity projects including, digital health solutions, SaMD, SiMD, AI/ML and CDSS.
    View
  • Fresenius Medical Care
    Senior Manager Regulatory Affairs - Devices
    Fresenius Medical Care Jun 2021 - Mar 2023
    Bad Homburg, Frankfurt, De
    Support new medical device and marketed product development. Directs preparation of US, Canada, Mexico and other international regulatory submissions for new products. Implement changes to existing products in compliance with applicable international and US federal laws. Provide leadership to a staff of regulatory professionals engaged in preparation of regulatory submissions in support of new product development and changes to existing products. Formulate and recommend regulatory policies and programs and maintain compliance with US and appropriate international regulatory requirements.
    View
  • Fresenius Medical Care
    Manager Regulatory Affairs - Devices
    Fresenius Medical Care Sep 2017 - May 2021
    Bad Homburg, Frankfurt, De
    Serve as Regulatory lead on project teams and act as the regulatory affairs subject matter expert for cybersecurity, new product development processes, Connected Health, software/AI and SaMD projects. Work closely with cross-functional and cross-divisional teams to improve product development processes.Responsible for ensuring timely preparation, review, authoring and submission of Pre-Submission, 510(k) and Note-to-File (NTF) documents.Manage regulatory timelines, provide strategic input as applicable and act as regulatory management reviewer for submissions authored by regulatory associates.
    View
  • Pixarbio Corporation
    Associate Director Regulatory Affairs
    Pixarbio Corporation Dec 2016 - Sep 2017
    Fort Myers, Florida, Us
    Led the preparation of submissions managing the FDA 505(b)(2) pathway with patented formulations of FDA approved bio-materials and FDA approved non-opiate drugs targeting key neurological areas to treat post-surgical pain.Reviewed clinical trial documents including clinical protocols/reports, investigator brochures, nonclinical reports, CMC protocols/test methods; review and approve clinical manufacturing plans and labeling.Responsible for developing long and short-term planning of regulatory projects that impact the company’s business plan, and developing strategies to ensure effective achievement of regulatory/business objectives.
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  • Encountercare Solutions
    Head Of Business Development / Regulatory
    Encountercare Solutions Jan 2010 - May 2016
    Developed Class II medical products and services for the chronic disease and substance abuse disorders markets.Completed regulatory impact assessments for design, labeling, and process changes as well as introduction of new advertising and promotional materials and medical education materials.Prepared regulatory submissions and oversaw the maintenance of regulatory filings to support U.S. and international marketing applications, applications under review by health agencies, and post-approval products.
  • Authentidate Holding Corp./Express Md Solutions
    Director Of New Projects
    Authentidate Holding Corp./Express Md Solutions 2009 - Jan 2010
    Us
    Authored the 510(k) for the Electronic House Call System (K090801), a home health monitor for the management of chronic disease patientsParticipated in new product development and life-cycle management projects to provide regulatory guidance, develop regulatory strategies, and author regulatory submissions.Licensed the product and system to a NASDAQ company.Secured the Veterans Administration national contract for the system.Responsible for setting up regulatory compliance and product manufacturing (cGMP).Team leader in licensing the product and system to ADAT and securing the National Contract for the Electronic House Call with the Veterans Administration in their Home Telehealth Program.
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  • Amd Global Telemedicine, Inc.
    Director Of Technology
    Amd Global Telemedicine, Inc. 2005 - 2009
    Chelmsford, Ma, Us
    Managed the regulatory affairs team responsible for strategic direction and decision making in support of global products including electronic stethoscope, medical scopes, general examination camera, telemedicine carts, vital sign monitors, ECG’s, retinal camera, and ultrasound probes.From 2007-2009, filled the role of product development and product development engineer on home health monitor development projects.Authored and reviewed 510(k) submissions including 30-Day Notices, Real-Time Supplements, Manufacturing Site Change Supplements, Annual Reports, Post-Approval Study ReportsUpdated EU Technical Files according to requirements of the European Medical Device Directive (EU MDD). Acted as regulatory management reviewer for Technical File updates by regulatory associates and held responsibility for Declaration of Conformity approvals.Coordinated technical sales, support and development of all products and services including electronic stethoscope, multiple medical scopes over broadband, the telemedicine industries top selling general examination camera, telemedicine carts, vital sign monitors, ECG’s, retinal camera, and ultrasound probes.
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  • Goodstuff Marketing
    Head Of Creative Services
    Goodstuff Marketing 2003 - 2005
    Responsible for designing and implementing traditional business marketing programs and promotions for Fortune 500 companies in US and Canada. From creative to interacting with the consumer at point of purchase and everything in-between. One stop shop - completely turn-key Full-service programs for brands including Pepsi, Dunkin Donuts, Cracker Jack, Lipton, Mountain Dew, Budweiser and M&M Mars.
  • Viatech Technologies
    Director Of Business Development
    Viatech Technologies 1997 - 2003
    Managed the development and design of the patented Electronic License System (Elicense). Created and hosted the first online store for Electronic Arts (EA) using online game codes.

Chris Doherty Skills

Healthcare Product Management Strategic Planning Medical Devices Healthcare Information Technology Start Ups Program Management Management Business Strategy Cross Functional Team Leadership Strategy New Business Development Strategic Partnerships Project Management Product Development Saas Leadership Entrepreneurship Account Management Marketing Strategy Business Development Process Improvement Hospitals Team Building Marketing Product Marketing Business Planning Customer Service Integration Electronic Medical Record Venture Capital Analytical Skills Executive Management Chronic Illness Internet Of Things Good Clinical Practice Healthcare Information Technology Public Speaking Clinical Research Sales Operations Sales Healthcare Management Product Launch Regulatory Affairs Regulatory Submissions Regulatory Compliance

Chris Doherty Education Details

  • Boston University School Of Medicine
    Boston University School Of Medicine
    Biotechnology
  • Boston College
    Boston College
    General

Frequently Asked Questions about Chris Doherty

What company does Chris Doherty work for?

Chris Doherty works for Fresenius Medical Care

What is Chris Doherty's role at the current company?

Chris Doherty's current role is Sr. Lead GRA Software & Cybersecurity at Fresenius Medical Care.

What is Chris Doherty's email address?

Chris Doherty's email address is ch****@****cna.com

What is Chris Doherty's direct phone number?

Chris Doherty's direct phone number is +178144*****

What schools did Chris Doherty attend?

Chris Doherty attended Boston University School Of Medicine, Boston College.

What skills is Chris Doherty known for?

Chris Doherty has skills like Healthcare, Product Management, Strategic Planning, Medical Devices, Healthcare Information Technology, Start Ups, Program Management, Management, Business Strategy, Cross Functional Team Leadership, Strategy, New Business Development.

Who are Chris Doherty's colleagues?

Chris Doherty's colleagues are Jennifer Draper, Kgaladi Marilele, Kevin Nye, John Cantrell, Disha Sundesha, Chandra Sekhar Kota, José Martin Rios Quispe.

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