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William J

Clinical Regulatory Affairs - 20 Years of Experience - Near 80023

Occupation:

Clinical Regulatory Affairs

Location:

Broomfield, CO

Education Level:

Master

Will Relocate:

YES

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SUMMARY OF PROFESSIONAL EXPERIENCE Regulatory, Quality, Clinical and Compliance Medical Executive with major milestones/achievements in the Life Science Industry. Over 30 years in Class III and Class II devices/allograft/biologics, inside/outside the United States (OUS) primarily in the fields of cardiology, cardiovascular, neurology, spine and orthopedics. Integral involvement with 80+ product categories. Personally prepared/directed and lead submissions to over 75 countries (European Economic Area (EEA), Pan Pacific countries and the Americas (Canada, Central, Latin, South and United States). Exceptional ability in ferreting out requirements/regulations throughout the world in terms of OUS and /or Federal/State requirements/regulations. Verified documentation as a strategic/ tactical leader to CEOs in regards to Product Development, Regulatory, Quality, Clinical and Compliance. Accomplishments: * Established FDA 21 CFR 820 Compliant Quality System * Established ISO 13485 Quality System * Selected Notified Body for ISO 13485 Certification and Medical Device Directive/CE Mark Accomplishments: * Contracted to revise/update an Internal Audit Program covering FDA, CE, MDD, JPAL, HC, ISO 13485 ($2B Healthcare Company) on time and under budget. * Seven Weeks in India establishing/coordination of ALL Compliance activities for a Multi-National Medical Products Company, two CE Marks, GCP/ ISO 14155, Usability Testing, IEC 60601 Testing, ISO 14971 Process, V/V Software activities, FDA strategy, NB strategy. * 30+ Page Power Point Presentation for the BOD of a Medical Products Company for achieving Regulatory Approval (PMA) in three major markets (US, Canada and Australia), including staffing, budgets, time lines, project plans, GCP/ clinical studies, investigational sites. * Five FDA Submissions, one (spine) cleared and four pending, three different Medical Products Companies, all on time and under budget * Completed Quality System (QM/SOPs/Forms/Templates) for a German Distribution (Orthopedic) Organization, on time and under budget to ISO 13485, four months start to finish * Nineteen STEDs conversions for a major Orthopedic Company. * Multiple Technical Assessments ($7B Healthcare Company) in the US, Scotland and Ireland for Supplier Quality Audits/GLP/GCP Regulations to decrease recalls via Joint Improvement Plans. * Four 510k's submitted/under review for Systems (ENT and Image Guided Brain/ENT/Orthopedic) * In depth (two weeks) GMP/GCP/GLP/21CFR820/Part 58 Audit of Manufacturer of Vascular Grafts in France with former FDA investigator/compliance officer/ director of enforcement branch chief. * Consultant to SFDA in Riyadh, KSA (FDA/EU/TGA/HC/JPAL Reviews), Reuse, OEM/OBL, GCP, GLP, Interim Regulations. Kingdom of Saudi Arabia Food and Drug Administration * 21 CFR 820 Mock Audit of CV Equipment Manufacturer, * Six Week Audit (21CFR820) of Manufacturer in Sweden with Six Team Members, Lead Auditor, * Clinical Evaluation Summaries (CES) for a Class III CV Manufacturer, 3 * Quality/Regulatory Strategies for IVD in the US/EU/CANADA (Microassay/Equipment/Biologic) to IEC 61010 and 62304 Series of Standards with IVD Harmonized Standards, * GLP Consulting to IVD Manufacturer, * Two ISO 13485/21 CFR Part 820 Quality Systems Established * Clinical Established in Tbilisi, Georgia with ALL documentation, less than two months start to finish * Regulatory Strategy for TAVI (OUS and US) Converted prior Notified Body (NB) to new NB * Addition to Scope for CE Marking (TUV), less than 60 days * Three Licenses to Health Canada (Approved), average time 40 days * 12+ Registrations OUS, increase in sales by 15% * Surveillance Audit with NB (TUV), reduction in observations by 25% * Three Product Lines Received 3rd Edition Certification (60601-1) (TUV), on time/under budget * INMETRO Audit for Brazil (NCC), on time * CCC Certification, allowed for replacement computers into China (PRC) COMPLIANCE/QA: * Resolved Major Compliance Issue with FDA SF District Office, averted additional FDA action * Closure of Class 2 Recall (80%+ Returns) * Averted Class 2 Recall, institution of revised policies * Commenced Class 3 Recall (55%+ Returns to Date) * Updated/Created Three TFs for NB (TUV), on time/under budget * Decreased Complaints/ECRs/CAPAs (30%) * No MDRs/Vigilance Reports * Updated QS/GCP SOPs (25+) within four months * Policy developed as to Released Product (ECR/FDA Clearance/Addition to Scope/Updated DHFs/Updated TFs) * Instituted RoHS Plan * Improved Release/Shipping of all Products by 40% * Directed/implemented new software policies/procedures for all new products * Instituted GLP Policy and Procedures AMTAC with updated Technical Files less than three months * Submitted Class III Design Dossier without Human Studies received Certificate in two months Wrote/Implemented PMS Study for Class III (EEA) Due Diligence as to HCT/Ps 21 CFR 1271 GCP Allografts acquisition of Surgical Biologics registrations as it pertains to interactions with Health Care Professionals (HCPs), First Compliance Program * Adopted AdvaMed Guidelines, on time/under budget * Member AdvaMed CCO Advocacy Group * Implemented first corporate-wide training, 100% trained * Established internal monitor/auditor with Finance * Developed policies and procedures with team of individuals (Finance) * Integral part of IPO process (FDA Counsel, SEC Reviews), stock oversold by 15% * Liaison with all Regulators/Agencies/Trade Associations as to Continuous Compliance Improvements including HIPAA/GCP/ICH/GLP Guidelines RA: Directed all regulatory strategies (US and OUS) involving new and modified devices. Responsibilities included planning, budgeting, labeling (IFU, STM, Advertising, Website (s), Marketing Collaterals, etc.). * Four 510 (k) s submitted/cleared, additional $12 Million in revenue * One Pre-IDE meeting with FDA's ODSB * Four 510 (k) s under completion * CE Mark Certification, on time/under budget increased sales by 10% * Product into Japan without MHLW registration through rare ordinance speeded registration process by 12 months Product into India as a custom device with Indian CDSCO Approval prior to the registration speeded registration by 18 months * Three ISO/MDD Audits with 75% reduction in minor observations (No majors) * Averted MAJOR recall worldwide after discussions with FDA and organizing independent review committee prevented product from being withdrawn from market * Numerous speaking engagements to OUS Scientific Advisory Board Meetings and Distributor

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COMPANY POSITION HELD DATES WORKED

(Confidential) Vice President Regulatory, Clinical And Compliance (Quality) 4/2015 - Present
Optovue Inc Vp Of Regulatory Affairs/Quality Assurance 12/2012 - 7/2013
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