Volunteer / Puppy Wrangler

• Mar 2021 - Present

Volunteer at a local non-profit organization that purpose breeds Labrador Retrievers for eventual donation to organizations to be trained as service dogs for veterans, children with special needs and adults with disabilities "Chaperone" Barbie (AKC name "Hey Bartender") (no lie!) a momma dog from Project2Heal that will birth several litters of puppies for donation Participate in outreach programs to schools, churches, & communities to socialize the puppies and share our mission Volunteer at a local non-profit organization that purpose breeds Labrador Retrievers for eventual donation to organizations to be trained as service dogs for veterans, children with special needs and adults with disabilities "Chaperone" Barbie (AKC name "Hey Bartender") (no lie!) a momma dog from Project2Heal that will birth several litters of puppies for donation Participate in outreach programs to schools, churches, & communities to socialize the puppies and share our mission

Retired

• Jan 2017 - Present

President

• Oct 2016 - Mar 2018

Founder of regulatory compliance consultancy, focused on development and implementation of global regulatory affairs and compliance strategies for medical device and in vitro diagnostic companies Specialties: FDA, QSR, ISO 13485, EU Medical Device and IVD Directives, regulatory intelligence, CAPA, complaints, recalls, postmarket surveillance, auditing, regulatory submissions, 510(k), training, validation, software, IVD, and and risk management. Founder of regulatory compliance consultancy, focused on development and implementation of global regulatory affairs and compliance strategies for medical device and in vitro diagnostic companies Specialties: FDA, QSR, ISO 13485, EU Medical Device and IVD Directives, regulatory intelligence, CAPA, complaints, recalls, postmarket surveillance, auditing, regulatory submissions, 510(k), training, validation, software, IVD, and and risk management.

Senior Vice President, Quality Assurance & Regulatory Affairs

• Feb 2012 - Oct 2016

Established overall strategic direction and operational coordination of activities for global regulatory compliance, with 21CFR Part 820, ISO 13485, ISO 14971 and other applicable global regulatory requirements for development and manufacture of high-precision Class III digital pathology devices and software solutions Developed and successfully implemented strategic plan for creating a robust quality management system in first year, resulting in initial ISO 13485:2003 certification at multiple sites, with no significant audit findings Established and directed team of regulatory professionals in the development/submission of European Technical Files, international registrations, 510(k)’s, and first-in-kind PMA for primary diagnosis of cancer using digital pathology systems

Quality Systems Business Group Partner / Manager, Quality Assurance & Regulatory Affairs

• 2002 - 2012

Internal consultant/expert/mentor to cross-functional global teams on all compliance activities related to FDA regulations/guidance, ISO 13485, international standards and regulations Managed team of regulatory professionals responsible for 510(k)s, EU tech files, worldwide submissions, CAPA, audits, complaints, adverse events, and recalls for Class II angiographic/CT/MR contrast media injectors & sterile disposables, MR coils, MR Compatible Infusion Pumps and MR Compatible Physiologic Monitors

Manager of Corporate FDA/DEA Programs

• 1996 - 2002

Responsible for corporate-wide compliance with FDA and DEA regulations for manufacture and distribution of over 600,000 products, including complaint management, supplier/facility audits, due diligence, Coordinated FDA & DEA inspections of bulk pharmaceutical chemical and in vitro diagnostic reagent manufacturing sites Responsible for corporate-wide compliance with FDA and DEA regulations for manufacture and distribution of over 600,000 products, including complaint management, supplier/facility audits, due diligence, Coordinated FDA & DEA inspections of bulk pharmaceutical chemical and in vitro diagnostic reagent manufacturing sites

Director RA/QA

• 1993 - 1996

Responsible for quality systems, regulatory affairs, technical publications, and overall compliance with EPA, FDA, and OSHA regulations for design and manufacture of Class II sterilization systems, dental operatories, and dental X-ray devices Responsible for quality systems, regulatory affairs, technical publications, and overall compliance with EPA, FDA, and OSHA regulations for design and manufacture of Class II sterilization systems, dental operatories, and dental X-ray devices