john clay

vice president quality assurance and regulatory affairs

About

An experienced regulatory affairs and quality management professional with a proven track record of accomplishments. An effective and innovative leader with hands on knowledge managing FDA inspections, ISO audits, FDA submissions, Canadian licensing and CE marking for various types of medical devices in both large and small organizations. Additional experience within Pharmaceutical Development Quality representing QA on CMC product development teams. RAPS - RAC (US) ASQ - CQM, CQE, CQA Specialties: Quality Assurance, Regulatory Affairs,and Compliance for Medical Device organizations and Development Quality Assurance in Pharma: Medical Devices and Pharmaceutical Development, Manufacturing Operations and Distribution.

Country

united states

City

philadelphia

Industry

medical devices

Skill

fda, capa, regulatory affairs, medical devices, quality system, design control, quality assurance, change control, quality auditing, regulatory submissions, iso 13485, quality control, ce marking, quality management, gmp, validation, medical device directive, iso 14971, pharmaceutical industry, iso, v&v, regulatory requirements, 21 cfr part 11, pma, biotechnology, r&d, regulations, supplier quality, clinical trials, sop, technology transfer, glp, gxp, cqa, fda gmp, document management, auditing, corrective and preventive action, u.s. food and drug administration, quality systems, complaint management, sterilization, iso standards, verification and validation, cqe, lifesciences, 21 cfr, haccp, life sciences

Experience

quality assurance director

in-vitro diagnostics

2018-2 - Present · 8 yrs 8 mos

Implement, direct, develop, and maintain quality systems to support commercial and development activities for a rapidly-evolving, diagnostic leader in individualized medicine. Comply with US and international regulations and standards as they apply to products manufactured in the United Stated and distributed to the US, China, Singapore, Canada, and Europe. Implement a robust Quality Management System (QMS) and develop key talent.

director, regulatory affairs and quality

medtronic-invatec

2008-12 - 2010-8 · 1 yr 9 mos

FDA Regulatory Submissions (Class 2 and Class 3) Pre-IDE's, IDE Reports, 510(k) Submissions, Complaint Handling, Medical Device Reporting, Document Control/SOP Development, Advertising and Promotion Review, Registrations and Listings.

director of regulatory compliance and quality assurance

maquet getinge group

2007-10 - 2008-12 · 1 yr 3 mos

Complaint Handling and Medical Device Reporting for Life Support Systems (Ventilators and Heart Lung Machines), Document Control, Change Control, Internal Auditing and CAPA, QSR Training

qa supervisor

chef francisco heinz

1984-1 - 1991-1 · 7 yrs 1 mo

Quality Control - Frozen Soup and Bakery Operations, HACCP, Microbial Sampling, USDA Pre-operational Inspections, Plant Sanitation Monitoring/SOP's, Pest Control Monitoring and Finished Goods Release

vice president quality assurance and regulatory affairs

in-vitro diagnostics

2019-6 - Present · 7 yrs 4 mos

associate director, regulatory affairs - pharmaceutical delivery systems

west pharmaceutical services

2011-4 - 2013-3 · 2 yrs

Regulatory Strategies, Product Development Teams, Design Controls, Combination Products/Device Constituent, Human Factors/User Studies, Drug/Device Master File Submissions, 510(k) Submissions, Advertising and Promotion Review.

director of quality

small bone innovations, inc.

2010-9 - 2011-4 · 8 mos

* Managed and directed the activities of the quality assurance staff of 5 professionals including incoming inspection and document control personnel for a medical device company manufacturing Class II and III orthopedic implants and instruments. * Corresponded with suppliers on quality issues and quality improvement including the qualification of new vendors, materials and processes. * Managed the CAPA and Internal Audit programs to assure problems were identified and addressed in a timely manner. * Interacted with Product Development on design control activities including new product validation and change control. * Prepared and participated in the management review process. * Managed the complaint handling process identifying high risk complaints for Medwatch reporting. * Developed and provided oversight for packaging validations, cleaning validations and sterilization validations for the various orthopedic implants and instruments.

regulatory affairs and quality compliance officer

mölnlycke health care

2003-9 - 2005-12 · 2 yrs 4 mos

Product Submissions, Complaint Handling, Medical Device Reporting, Marketing/Advertisement and Promotion Review, Document Control, Field Corrections and Recalls, Registrations and Listings, Supplier Audits.

director, regulatory affairs and quality compliance

international technidyne corporation

1998-4 - 2003-9 · 5 yrs 6 mos

510(k) Submissions, Internal Audits, Complaint Handling, Medical Device Reporting, Management Reviews, Marketing, Advertising and Promotion Review, Document Control, FDA Inspections, ISO Audits, Management Representative, Technical Files and Design Dossiers (MDD and IVDD)

director of regulatory affairs

origio

2013-3 - 2015-5 · 2 yrs 3 mos

Regulatory Affairs and Compliance: Manufacturing specialized micropipets, cryopreservation devices and custom IVF workstations and incubator systems and accessories used in assisted reproductive technologies and in-vitro fertilization procedures. 510(k) Submissions, Technical Files, International Registrations, Canadian Licensing, Establishment Registrations and Listings, Corrections and Removals.

regulatory affairs manager

ethicon, inc.

2005-12 - 2007-10 · 1 yr 11 mos

Product Submissions, Design Controls, Regulatory Strategy/Assessments, PMA Annual Reports, PMA Supplements, Pre-IDE Meetings, CE marking, Establishment Registration/Device Listings, Advertising and Promotion review

director of quality assurance

b. braun medical

1991-8 - 1998-4 · 6 yrs 9 mos

Quality Control Inspection, Incoming inspection/Supplier Quality, Complaint Handling, Medical Device Reporting, CAPA, Internal Audits, Quality Engineering, FDA Inspections, Management Representative.

senior manager, cmc development quality compliance

ferring pharmaceuticals

2015-8 - 2018-2 · 2 yrs 7 mos

Headquartered in Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.