Sharon Resnick 🎗️ Email & Phone Number

Petaẖ Tiqwa, Central, Israel

QA/RA consulting to medical device companies to help them achieve their regulatory success and get their products on the market. • Develop regulatory strategies• Lead end-to-end programs for medical device clearance in EU and US markets• Establish and update effective and compliant quality systems, assist in creation of technical documentation and submission to regulatory authorities• Quality auditing to 21CFR Part 820, ISO 13485:2016, MDSAP, EU MDD/MDR• Quality-related trainings, mentoring and guidance• Retained services as QA/RA Manager in various companies

Petaẖ Tiqwa, Central, Israel

Drove the Quality and Regulatory vision and plans, established and implemented regulatory best practices, technical standards, laws and regulations and regulatory programs.• Executed company's quality objectives• Ensured full quality and regulatory compliance• Ensured site audit readiness and hosted Quality System audits• Owned and conducted internal audits• Conducted continuous improvement of Supplier Quality• Analyzed and communicated regulatory trends and their implications for the site• Led and supported continuous improvement activities

Tel Aviv, Israel

Regulatory affairs for medical devices course - FDA QSR, ISO 13485, MDSAP, internal and external audits

Israel

QA/RA consulting to medical device companies to get their products to market. • Developed regulatory strategies• Led end-to-end programs for medical device clearance in EU and US markets• Prepared Technical File(s), DHF, DMR• Established Quality Management Systems according with ISO 13485 and 21 CFR Part 820 requirements and applicable regulations (e.g., Health Canada, Brazil, Australia, etc.) as well as trainings and implementation.• Submitted Technical File to relevant Regulatory authorities• Interacted with the authorities/Notified Bodies until certification or clearance was obtained.• Established new quality management system and successfully passed external audits.• Participated in remediation projects (corrective actions and improvements following major noncompliance issues).• Conducted internal audits and prepared companies for external inspections (ISO 13485:2016, Medical Devices Directive 93/42/EEC, FDA QSIT Inspections, unannounced audits and MDSAP) including trainings and operational readiness.

• Harmonized, updated and maintained the Philips QMS in the Business Unit and implemented organizational excellence.• Managed the Business Unit’s regulatory affairs to obtain regulatory approval of its products as efficiently and effectively as possible in USA, Europe, Australia & NZ, ASEAN, LATAM, Russia and other emerging markets.• Managed 4 V&V engineers • Led the product risk management processes throughout the life cycle of the device. • Prepared Technical File(s), DHF, DMR• Responsible for Customer Complaints, vigilance and recall.• Authorized product releases including changes.• Conducted management reviews on a quarterly basis.• Managed government inspections and Third-Party audits.

Petaẖ Tiqwa, Central, Israel

• Successfully establishing and maintaining the quality management system.• Initiating and managing the accreditation project that eventuated in obtaining ISO 13485, CE and FDA accreditation. • Developing new policies, procedures and work instructions for the organization.• Auditing the quality management system, working with Development, Customer Service, and V&V on improving processes and product quality.Served as Operations Manager responsible for supply chain (import/export, customer order handling, suppliers management), infrastructure and work environment, human resources and welfare.

Cmq/Oe, Certified Manager Of Quality And Organizational Excellence

Iso 13485:2016 Lead Auditor, Auditing Medical Device Quality Management Systems

Project Manager, Project Management

Leadership, Vector Program

Green Belt, Dmaic 6 Sigma