Alwin Francis Damasus

About Alwin Francis Damasus

I am a Regulatory Affairs and Quality professional with 3+ years of experience supporting medical device and pharmaceutical products across development, post-market surveillance, and global regulatory compliance. My work spans EU MDR/IVDR, PMS/PMCF, technical documentation, risk management, CAPA, and audit readiness, with a strong ability to collaborate across R&D, Quality, Manufacturing, and Supply Chain teams.Currently at Smith & Nephew, I support regulated laboratory operations and product development activities within a highly controlled medical device environment. Previously, I supported Class post-market surveillance initiatives, complaint trending, and risk management updates aligned with FDA and EU MDR requirements, and earlier built a strong QA/RA foundation through GMP documentation, change assessments, CAPA execution, and inspection readiness, contributing to successful audits and measurable quality improvements.Beyond hands-on execution, I bring a regulatory mindset focused on clarity, compliance, and practicality, translating complex regulations into actionable outcomes that support safe, compliant product lifecycles. I value strong cross-functional partnerships and thrive in environments where rigor, accountability, and continuous improvement drive results.I’m open to connecting with professionals across Regulatory Affairs, Quality, Medical Devices, and Healthcare Innovation to exchange perspectives and explore opportunities to make meaningful regulatory impact.

Experience

1. Lab Assistant Test Engineer

   Smith Nephew

   Nov 2025 — Present

   Manage daily operations of a regulated medical device laboratory, ensuring compliance with ISO 13485, FDA QSR, GMP, GLP, and EHS requirements-Own the laboratory equipment lifecycle, including calibration, preventive maintenance, troubleshooting, repair, asset tracking, and lifecycle management-Perform software installation, upgrades, and configuration for laboratory instruments and electro-mechanical systems across Windows and Linux environments-Maintain asset tracking, inventory control, procurement, and shipment coordination to ensure uninterrupted laboratory operations-Support laboratory testing by preparing samples, executing routine and specialized tests, and documenting test results and metadata-Develop, update, and enforce SOPs, and train laboratory personnel on technical procedures, safety protocols, and troubleshooting-Collaborate cross-functionally with R&D, Quality, Manufacturing, and Supply Chain teams to support product development, validation, and audit readiness.

Education

• Northeastern University

  Master's degree, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs

• Chordia Institute Of Pharmacy

  Bachelor of Pharmacy - BPharm, Pharmacy