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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, 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.All aspects of Regulatory Affairs * Quality * Compliance * Risk MitigationCollaborative leadership * Change Management * FDA QSR * MDSAP * EU MDD * EU MDR * ISO13485 * ISO14971Certified Lead Auditor ISO13485:2016 * Audit Preparation and Regulatory SupportVeteran - United States Air Force, Electronic Warfare, Secret clearance𝗘𝗺𝗮𝗶𝗹 𝗰𝗼𝗻𝘁𝗮𝗰𝘁 𝗶𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻: 𝗺𝗶𝗰𝗵𝗮𝗲𝗹.𝗴.𝘃𝗮𝗻𝗿𝘆𝗻@𝗴𝗺𝗮𝗶𝗹.𝗰𝗼𝗺
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Senior Manager Regulatory AffairsGetinge Feb 2024 - PresentGothenburg, Se -
Senior Regulatory Affairs, Compliance Manager, Lifecycle And Process ExcellenceBd May 2021 - Oct 2023Franklin Lakes, New Jersey, UsProcess 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. -
Senior Manager, Quality AssuranceVarex Imaging Corporation Jun 2018 - May 2021Salt Lake City, Ut, UsSite 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 audit.• Conducted domestic and international regulatory submissions for radiological devices.• FDA 510(k) submissions: K193238, K190146, and K183212. -
Sr. Staff Regulatory Compliance SpecialistStryker Jan 2016 - Jan 2018Kalamazoo, Mi, UsCorrections and Removals management for orthopedic, robotic-assisted surgical devices, and surgical tools.• Served as Key Regulatory contact for product recall data.• Supported Quality System audit.• Acted as CAPA and Kaizen owner and facilitator. -
Lead Regulatory Engineer, Post Market SurveillanceWelch Allyn Apr 2010 - Dec 2015Skaneateles Falls, New York, UsProcess 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.
Michael Van Ryn Skills
Michael Van Ryn Education Details
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Ursinus CollegeCommunications/Marketing -
Penn State University-Great ValleyInstructional Design And Technology
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Community College Of The Air ForceAvionics Systems Technology
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Electronic Warfare School, Keesler Afb, MsElectronic Warfare Systems
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Penn State UniversityEducational/Instructional Technology
Frequently Asked Questions about Michael Van Ryn
What company does Michael Van Ryn work for?
Michael Van Ryn works for Getinge
What is Michael Van Ryn's role at the current company?
Michael Van Ryn's current role is Sr. Manager, Regulatory Affairs at Getinge.
What is Michael Van Ryn's email address?
Michael Van Ryn's email address is mi****@****lyn.com
What is Michael Van Ryn's direct phone number?
Michael Van Ryn's direct phone number is 131528*****
What schools did Michael Van Ryn attend?
Michael Van Ryn attended Ursinus College, Penn State University-Great Valley, Community College Of The Air Force, Electronic Warfare School, Keesler Afb, Ms, Penn State University.
What are some of Michael Van Ryn's interests?
Michael Van Ryn has interest in Animal Welfare, Skiing, Cycling.
What skills is Michael Van Ryn known for?
Michael Van Ryn has skills like Ultrasound, Pacs, Medical Devices, Fda, Clinical Trials, Medical Imaging, Iso 13485, Quality Systems, Regulatory Affairs, Validation, Product Development, Capa.
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