Canada
At the helm of Traferox Technologies' regulatory affairs, my focus is on navigating complex regulatory landscapes, particularly in the realm of higher risk combination products. My recent accomplishments include getting the first bundled 510(k) clearance for organ preservation systems and organ preservation solutions. My other responsibilities include: driving premarket approvals and ensuring alignment with the EU Medical Device Regulation (EU MDR), demonstrating our organization's readiness for the evolving global market demands. Championing regulatory strategies, I leverage a decade's insight to lead our organization toward innovative solutions while adhering to the highest regulatory expectations.
I have moved to Ontario, Canada, and actively looking for Medical Devices/ IVD RA and QA job roles. Open for full-time, hybrid, and remote job opportunities.
Worked on the implementation of ISO 13485:2016. Main tasks involved: Updating and maintaining the Quality & Regulatory procedures as per ISO 13485 and applicable regulations. Training multi functional team on the requirements of ISO 13484:2016 Coordinating with multi functional team for drafting departmental procedures as per ISO 13485:2016 and QSR. Working on the corrections and corrective actions for timely closure of NC's and responding to certification body. Experience of working on risk management and usability engineering files for different products. Faced certification audit for ISO 13485:2016 and MDSAP. Regulatory activities undertaken: Updating and maintaining the technical file for class IIa and class I medical device. Coordinating with European AR and sharing the updated technical file. Managing the significant changes and coordinating with regulatory authorities. Managing the product certifications in Malaysia, Canada, Saudi Arabia, Nigeria and US. Spearheaded the cleaning the disinfection activity for a eye contact device (semi critical)-Drafting the protocol, doing the literature search, coordinating with US based testing lab, performing in house simulating studies and getting the final report. Coordinating with team for a successful 510(k) submission. Worked on preparing and updating the clinical evaluation plan and CER as per MEDDEV guidelines for class IIa and class I device. Coordinating with BIS labs for testing of products under CRS.
Worked for QMS implementation as per ISO 13485. Involved in understanding the national and international regulatory compliance for the novel biopsy device. Actively involved in the research studies with hemostatic agents, class III devices. Preparing clinical evaluation reports as per Meddev 2.7/1 edition 4. Knowledge of MDD directive and related standards. Worked on Risk Management with other team members for the novel biopsy device. Preparing the required documentation for CDSCO approvals. Meeting the drug officials with respect to registration of the medical device. Worked on SFDA for class IIb medical device registration in KSA market.