PRRC, Quality and Regulatory Representative

• Manage portfolio of assigned projects
• Provide Quality and Regulatory guidance in product development projects
• Lead the R&D team in the writing of the MDR/FDA technical documentation
• Perform inspections and audits
• Ensuring QMS and technical documentation compliance with relevant standards and regulations such as ISO 13485 (QMS), EU/2017/746/IVDR, and 21 CFR Part 820
• Monitoring regulatory updates and ensuring the QMS reflects current requirements
• Write clinical Evaluation plans and reports

• Planning Technical documentation update for transition IVDD to IVDR
• Update Technical documentation and prepare techfile review by Notified Body
• Lead the team for the readiness of the IVDR CE Conformity Assessment
• Provide guidance for Products development to R&D Team

• Manage portfolio of assigned projects and provide functional expertise in area of responsibility for medical devices and combination products
• Provide Quality and Regulatory guidance in development projects of combination devices
• Write, review and approve deliverables to ensure GMP compliance
• Support Medical Device Risk Management, through proactive risk management tools and approaches, to minimize impact on global supplies and patients
• Release of medical devices for clinical studies and commercial use
• Perform inspections and audits

• Provides regulatory support for R&D product development to ensure compliance to regulatory requirements for desired markets around the globe
• Works to prepare and submit technical documentation to regulatory authorities for obtaining authorization for market launch
• Develops regulatory strategies to guide regulatory submission pathways
• Write the Product Security Risk Management procedure
• Perform the Product Security Risk Management activities and documentation for connected device
• Lead the Product Safety Risk Management activities and documentation
• Write the Product biological safety evaluation
• Write and support the achievement of the product clinical evaluation report
• Support the usability activities and write the usability Engineering File
• Review the Design and development documentation, support and guide R&D Team

• Write Usability Engineering Procedure and Templates compliant to IEC 62366-1:2015
• Write Usability Engineering Files for Products DHF
• Update DHF documentation according to ISO13485:2016, MDR, QSR, MDSAP and Regulatory Requirements
• Write Regulatory Documentation for Product Certification
• Improve and Perform Risk Management according to ISO14971
• Determine gaps in processes/instructions particularly for IEC 62304 development
• Preparation and monitoring of audits
• Process complaints and CAPAs
• Supplier Management

• Quality and Regulatory guidance for R&D projects
• Drive the team for R&D documentation through development phases
• Remediation of DHF files and product documentation
• GMP and Corporate Audits Support
• QMS optimization
• Write Usability Engineering File according to IEC 62366
• Perform design reviews for R&D projects
• Deal with R&D department CAPAs

• Project leader for Unique Device Identification/Direct Part Marking (DPM)
• Compose project strategy plan and documentation
• Lead product technical documentation review
• Update Risk Management documents
• Lead change requests for DPM implementation
• Work with R&D, Manufacturing, Quality and Regulatory Affairs
• Update DHF and Technical documentation

• Create project structure and assign responsibilities
• Writing regulatory requirements
• Analyze failures in DHF and develop solutions
• Design resolution plans for failures
• Implement solutions through CAPAs

• Process Improvement (Risk Management, Calibration, Inspection, Test and Release)
• Writing SOPs and work instructions
• Updating Risk Management File
• Update Manufacturing Processes
• Writing legacy review reports and remediation plans

In Charge of:

• Document Management System Administration
• Quality documents revision
• Internal Audits and supplier audits
• Supplier Qualification and Management
• Testing and inspection
• Writing SOPs and work instructions

Project: Optimization of QM System according to ISO 13485, 21CFR Part 820 and 21CFR Part11:

• Documentation Control process
• Internal Audit Process
• Corrective and Preventive Action Process
• Quality Control Process
• Risk management process
• Validation process
• Suppliers Management process
• Change Management process
• Design control process

Main Subject: Astrophysics and elementary particle physics