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

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

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

• 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.

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.

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