michael van ryn

About

Professional Qualifications: Extensive experience in the servicing and support of sophisticated electronic equipment, medical imaging systems and computer products in a variety of specialized markets. Extremely proficient in resolving complex technical and non-technical problems with minimal assistance while maintaining and demonstrating subject matter expertise as well as technical superiority and skill in the repair and maintenance of sophisticated electronic products and devices. Analyzes complex production and quality trend data to identify and solve problems. Devise sampling procedures and designs and develops systems for recording, evaluating, and reporting quality and reliability data. Perform economic implication analyses, prepares reports of findings and carries out complicated implementation and training assignments. Completes and maintains quality inspection programs for incoming, process, and final approval material and product inspections. Conducts audits and/or surveys to determine acceptability of quality controls. Possess outstanding customer service skills.

Country

united states

City

liverpool

Industry

medical devices

Skill

ultrasound, pacs, medical devices, fda, clinical trials, medical imaging, iso 13485, quality systems, regulatory affairs, validation, product development, capa, healthcare, quality management, quality assurance, cardiology, documentation, cross functional team leadership, risk management, qsr, team leadership, sap, electronics, quality auditing, compliance, quality system, software documentation, process improvement, radiology, hardware diagnostics, capital equipment, testing, complaint management, digital imaging, market development, biomedical engineering, product launch, manufacturing, mri, r&d, field service, 21 cfr, operating room, commercialization, clinical research, gmp, design control, v&v, spc, corrective and preventive action

Experience

senior staff regulatory compliance specialist

stryker

2016-1 - 2018-1 · 2 yrs 1 mo

Global post-market compliance activities involving product corrections and removals for the Joint Replacement division of Stryker. Responsibilities include: Supports all aspects of product recall management and post-market surveillance activities for the Joint Reconstructive Division. Prepares technical regulatory submissions for FDA Acts as the primary contact between Stryker Mahwah and the FDA District Office, Stericycle and Competent Authorities. Provides external audit and inspection support for FDA QSR, ISO 13485 and other regulatory bodies Kaizen and Lean proces facilitator NC/CAPA owner and root-cause investigator Supports Operations and Supplier Quality in the NC/CAPA process Quality Management System process owner Quality Systems auditor Regulatory and Compliance training facilitation Creates ECR/ECN/CA for Compliance procedures Project manager for Regulatory Compliance activities

senior regulatory engineer, global high risk complaints

welch allyn

2010-5 - 2015-10 · 5 yrs 6 mos

Global Field Corrective Action Project Manager for Class I and II medical devices field corrective actions. Utilized key quality and regulatory principles, tools and practices to optimize systems and processes that are aligned with the overall business and the Quality Policy. Supported manufacturing by addressing quality events related to product release including non-conformance, product disposition, root cause investigation, and corrective/preventative action (CAPA). Managed the divisional regulatory reporting process for regulatory actions to ensure overall compliance with applicable regulatory and statutory requirements. Conducted root-cause investigations on Class I and Class II medical devices and reduced the open failure investigation backlog by 64%. Led a team of 4 engineers that dispositioned over 7,000 high-risk complaints per year and submitted over 350 Medical Device Reports (MDR) to FDA

imaging analyst, clinical research

orthovita

2009-7 - 2010-5 · 11 mos

* PACS Administrator for Clinical Research medical data and images acquired from clinical sites. * Electronic Data Collection Administrator responsible for the creation and maintenance of Clinical Research Forms used in Clinical Studies * Review clinical study data with Clinical Research personnel. * Assist Clinical Affairs and Product Management personnel in review and selection of radiographic data. * Provide medical imaging and modality training to staff.