Chris Doherty Email & Phone Number

Wills Point, Tx, Us

Bad Homburg, Frankfurt, De

Global regulatory lead for all software and cybersecurity projects including, digital health solutions, SaMD, SiMD, AI/ML and CDSS.

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.

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.

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.

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.

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.

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.

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.

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.

Bioscience Academy - Certificate In Applied Biotechnology, Biotechnology

Bachelor'S Degree, Biology/Biological Sciences, General