### Tasks & Responsibilities ###

• Serving as the single point of contact: for technical conversations with third party device manufacturers regarding design controls, risk management, and agreements. Act as the Subject Matter Expert (SME) on device requirements and technical nuances; also ensure these elements are appropriately integrated into study protocols and documentation.
• Compile and maintain the "Asset List" (Technical Documentation), perform technical reviews of manufacturer data, and author or review technical content for submission documents.
• Digital & Regulatory Identity: Co-lead the regulatory characterization of DHTs with the Product Management & Design Leaders, which involves providing input into Roche-s internal Device Regulatory Assessment and supporting updates.
• Change Control: Act as the intake point and primary assessor for changes during a study, rigorously evaluating the impact on technical accuracy, documentation, and overall study integrity. Work will also help inform third party manufacturers of updates needed in their design control documentation.
• Evaluation: Support manufacturer qualification activities with Quality, Product Managers, Business Strategy & Operations and Procurement teams to evaluate vendor capabilities and identify technical gaps to inform viability of use as a third party manufacturer.
• Remediation: Oversee the manufacturer's delivery and lead any needed remediation efforts (when needed) to address updates to documentation.
• Review Manufacturer Design History Files (DHFs) and product development documentation: from the third party DHT product manufacturers.
• Conduct Risk Management and computer systems validation (CSV) for products not classified as medical device, when necessary and per Roche-s global standard operating procedures (SOPs).
• Ensure compliance with Roche-s internal quality standards and global standard operating procedures (SOPs) for medical devices, including sourcing, clinical investigation, risk management, and clinical performance procedures.
• Draft or support product managers, clinical scientists, or other clinical teams with drafting technical documentation or risk management plans to meet Roche SOP, ISO standards or Health Authority Requirements.
• Support upskilling: activities and plans to train team members new to medical device development, design control, regulatory assessment and quality documentation activities.