As a team player, ability to interact with cross functional teams to understand the intended use & features of SaMD (developed in Agile and Waterfall methodologies) and perform gap assessment.
Apply the knowledge of standards like IEC 62304, IEC 82304, IEC 62366, ISO 14971, and ISO 13485 to link and address the applicable safety, clinical and risk elements effectively to the SaMD product under development.
Develop QMS documents and regulatory dossiers wrt SaMD products.
Involve in document review, raise tickets (in JIRA tools) for change control, manage control of electronic records (in Google Suite), SOUPS/OTS validations, external testing (VAPT, Cybersecurity) and SaMD product releases.
Oversee the verification & validations performed to ensure that they meet the FDA regulated environments.
Write test/use cases to check/verify that the SaMD product meets the intended use as per the claim.
Manage the RIMS (Regulatory Information Management System) portals like MD Online (Sugam) and e-STAR (USFDA) for regulatory submission, responding to the queries from medical device authorities and notified bodies.
Be part of internal and external audits of ISO 13485, ISO 27001, HIPAA and MDSAP to maintain the existing certifications.
Do sanity check on the marketing contents posted in website, collaterals, and social media handles to ensure the intended use and claim statement are in alignment with the quality and regulatory compliance for SaMD.
Actively participate in weekly team meetings to update about the progress made on the projects/tasks assigned.
