MICHAEL G. VAN RYN

Marcellus, NY ***** 315-***-**** www.linkedin.com/in/michaelgvanryn

REGULATORY AFFAIRS AND QUALITY MANAGEMENT LEADER

Accomplished Regulatory Affairs and Quality Management Leader in the medical device industry (radiology imaging equipment, orthopedic implants, physical assessment devices, electro-mechanical medical devices, and Software as a Medical Device (SaMD)) with expert knowledge of regulatory submissions, strategy, training, standards, and compliance. Extensive Global experience in Regulatory Affairs and Quality Systems and the ability to connect regulatory initiatives to overall business objectives. Collaborative and pragmatic leader who drives high-performance teams focusing on facilitating positive change within organizations to address compliance and quality issues by promoting a collaborative work culture with a strong emphasis on teamwork, accountability, and compliance.

AREAS OF EXPERTISE

Regulatory Compliance Quality Control Project Management Risk Management Leadership GMP (Good Manufacturing Practices) FDA Regulations Standards Management Regulatory Submissions Quality Auditing Documentation and Process Management

PROFESSIONAL EXPERIENCE

BD, San Diego 2021 - 2023

Senior Manager, Regulatory Standards and Compliance, Medication Management Solutions

Process owner responsible for managing international and domestic standards implementation through the timely sensing and their impact to products or processes.

•Served as Quality System Audit support as Regulatory Lead and Subject Matter Expert.

•Acted as CAPA owner and facilitator.

•Provided New Product Development, Sustaining Engineering, Medical Affairs, and Risk Management teams with critical Regulatory support to resolve compliance issues, customer issues, and ensuring performance of distributed products.

•Managed targeted improvement projects and activities to successfully mitigate identified compliance gaps by reducing a backlog of standards assessments by 93%.

•Zero audit non-conformances for standards management.

VAREX IMAGING CORPORATION, Salt Lake City, UT 2018 – 2021

Senior Manager, Global Quality Assurance, Site Management Representative (Liverpool, NY)

Site Quality Management Representative responsible for all aspects of quality assurance and regulatory affairs activities at a radiological device and SaMD development and manufacturing site.

•Served as Global Supplier Quality Manager with 9 direct reports in 2 countries.

•Supported Quality System audits.

•Created QMS and RA training curriculum to support external audits

•Conducted domestic and international regulatory submissions for radiological devices.

•Led Cost of Quality project which reduced out-of-box failures by 25%.

•FDA 510(k) submissions: K193238, K190146, and K183212.

STRYKER ORTHOPEDICS, Mahwah, NJ 2016 - 2018

Senior Staff Compliance Specialist, Joint Replacement Division

Corrections and Removals management for orthopedic, robotic-assisted surgical devices, and surgical tools.

•Served as Key Regulatory contact for product recall data.

•Supported Quality System audits.

•Developed and conducted Regulatory training to Sales and Marketing teams

•Acted as CAPA and Kaizen owner and facilitator.

WELCH ALLYN, Inc., Skaneateles Falls, NY 2010 - 2015

Global High-Risk Complaints & Post-market surveillance Manager

Process owner for FDA Medical Device Reporting and Global Adverse Event Reporting (EU, Canada, and Australia).

•Served as Process owner for Global Field Corrections and Removals Management.

•Facilitated root-cause investigations for reportable complaints.

•Conducted internal quality audits in manufacturing.

Siemen Medical Solutions, Malvern, PA 2004 – 2009

Regulatory Affairs Manager

Process owner for Post-Market Regulatory surveillance for X-Ray, Mammography, Computed Tomography, Magnetic Resonance Imaging, and Picture Archiving and Communication Systems.

•Served as Process owner for US Complaints, Adverse Event Reporting, and Field Corrections and Removals.

•Facility registrations and renewals

•Certificates of Foreign Governments administration

•Supported activities pursuant to 21CFR 814 Subpart E for the following PMA submission:

oPMA P030010, SIEMENS MAMMOMAT INSPIRATION FULL - FIELD DIGITAL MAMMOGRAPHY SYSTEM

EDUCATION

Graduate courses in Instructional Design

The Pennsylvania State University

Cum Laude in BA Communications/Marketing and Fine Arts

Ursinus College

Associates degree in Avionics Systems Technology

Community College of the Air Force

PROFESSIONAL CERTIFICATIONS

ISO 13485:2016 Lead Auditor (Certificate Number: 26130144)

MILITARY SERVICE

Veteran-United States Air Force, Airborne Electronic Warfare

Secret Clearance, Honorable Discharge

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