Parin Shah

Quality & Regulatory - Regulatory Strategy - Regulatory Submission (EU, USA, world) - Clinical Evaluation Report - Post Market Surveillance - Risk Management - CAPA Management - Internal Audits

- Driving change by leading the EU MDR Implementation Project within the company - Functional and disciplinary lead of Regulatory Affairs professionals for project support and international registrations - European Authorised Representative and Person Responsible for Regulatory Compliance based on EU MDR - "Sicherheitsbeauftragter" & "Medizinprodukteberater" acc. to "Medizinproduktegesetz" (MPG) - Internal Auditor acc. ISO 13485

- Responsible for Medical Device Registrations worldwide (incl. Dental) - Writing and reviewing technical documentation according to MDR - Planning PMS/PMCF activities according to MDR - Writing clinical evaluation according to MEDDEV 2.7/1 and MDR

- Responsible for CE instruments, implants & endoscopes (Class I, IIa, IIb, III incl. disposables) - contact Person for notified bodies - testing & approval strategies for worldwide distribution - mentored R&D, Product Management, Purchasing, Production - monitored standards &requirements in development - optimized QMS processes (13485, 14971, MDR, FDA) - coaching of development team - negotiated OEM constellations with external suppliers - performed internal audits & external audits

- developed regulatory approval plan & strategy for Class II, III implants for Europe, Asia, Africa and South America - assisted with customer inquiries for registrations and legalization processes - collaborated in development projects: technical and scientific literature research, data analysis & clinical evaluation (MEDDEV 2.7.1) - prepared reports for post market surveillance (z.B. Vigilance, PSUR) - supported, reviewed and documented animal & clinical studies

Regulatory Affairs