SUMMARY OF QUALIFICATION • Regulatory Specialist experience in the medical/surgical device field with Class I, II and Class III devices • Representing General, Orthopedic, Spinal, Neurosurgical devices. • Experienced working knowledge of EN ISO 13485, EN ISO 14971(FMEA), 21 CFR 820, • EU MDD 93/42/EEC (2007/42/EC) Tech file assessment & remediation, JIST related PMES EN 60601-1(3rd ed.) and collateral standards and successful implementation. • Medical Device Regulation (EU MDR) aligned for implementation preparedness. • Strong working knowledge and demonstrated leadership of Global Medical QA & Regulatory requirements and registration procedures including all IFU, UDI, GTIN, relative product labeling requirements. Considerable Global standards acumen. • Strong medical and product technical writing skills. Experienced with development and maintenance of all QA document types including collection, software process mapping and management systems. (SAP,Windchill/PLM, ETQ, MS Office.) • Experienced in Process capability analytics (QE), PPAP, PFMEA, GR&R, and Mini-tab, DOE / Testing • Protocol and process validation proficient. • FDA QSR, EN ISO 13485, CE, CMDR, JPAL surveillance and Audit experience • Complaint investigation & handling specialist-MDR experienced/CAPA experienced. • Compliance Audit hosting, planning and follow up management proficient. • Excellent oral and written communication skills with project management and technical writing. PROJECT DETAILS Client: Terumo Medical, MI Regulatory Affairs Specialist Jan’2017 - Present • Create Regulatory strategy for EU MDD and create necessary regulatory pathway and training and implementation tools per EU MDR Article 120 requirements. • Management of assigned labeling projects and engineering team contributor for completion of labeling compliance changes. • Prepare, train staff and implement necessary tools for EU MDR implementation for franchise QA, RA personnel. • Train RA staffers in correct gap assessment and implementation of Global ISO and EN ISO (Harmonized) standards for compliance deliverables for implantable for spinal surgery devices tools and instrumentation. • Routine investigation of production and field quality issues relative to current and legacy trauma-orthopedic instruments and implanatable. • Support the preparation of document packages to notify regulatory field agencies and notified bodies of field action activities. • Contribute toward US and OUS field action execution activities. Organize and lead Field Action Strategy Team Meetings. • Provide updates to the FDA and global regulatory agencies. Process and close Field Actions in a timely manner as per FDA and European Vigilance regulations (21 CFR 7, 21 CFR 806, 21 CFR 810, and MEDDEV 2.12-1, rev 8). • Act as support for FDA and regulatory inspections. Initiate and manage Corrective and Preventative Actions (CAPAs) and CAPArelated Action Plans. Milestone medical, Fall River, MA Regulatory Affairs Specialist Jan’2015 – Dec’2016 • Provide support for currently-marketed products. This includes reviewing product/manufacturing process changes, supplier changes, new and revised engineering protocols and reports. Communicate to the department whether further notification to outside parties is required. • Team with Regulatory Affairs Specialists (RAS) and international regulatory staffs to provide regulatory support for changes to existing products. • Resolve potential regulatory issues and questions from regulatory agencies by coordinating responses from engineers and technical experts. • Facilitate renewals and amendment submissions in Canada, China, Taiwan, Countries, and EU countries. • Support manufacturing site transfer by planning and coordinating with international countries to successfully submit appropriate documentation in a timely manner • Helped with regulatory transitions for EU MDR compliance • Disseminate biocompatibility, shelf life, packaging, sterilization and design verification and validation results by compiling product information and reports. • Apply principles of FDA 21 CFR 820, SOP, GMP, ISO 13485, ISO 14971, etc. GlaxoSmithKline, New jersey, Regulatory Affairs Specialist Jan’12 - Dec’14 Responsibilities: • Maintained and created Technical Dossiers. Maintained and updated Technical Files • Compose technical justifications and statements for international requests regarding Class I, Class II and Class III medical devices, and corresponding accessories and tools • Collaborated with cross functional teams for various projects. Assisted in the submission of a Special 510(k) • Provide regulatory aid for product changes • Assisted in the creation of a Class III medical device submission to Health Canada • Completed a Change Control certification course • Created and signed off on many change requests and change orders
