Sebastian L. Email & Phone Number

Boston, MA, US

Waltham, Massachusetts, United States

Miami/Fort Lauderdale Area

• Improve internal report process according to 21 CFR Part 803, 820, and risk management tools (FMEA), decreasing number of MDR reported events by 22%
• Identify inefficiencies between internal software and FDA’s MAUDE database, solving inaccurate data reporting
• Work closely with Exec. Director of Quality Assurance on CAPA and NCN projects
• Develop competitive analysis project using FDA MAUDE and Total Product Life Cycle, supporting Post-Market Review team’s trending reports
• Maintain regulatory compliance by collaborating with QC and Customer Care departments on CAPA projects
• Owning and leading CAPA projects; planning investigation, risk assessment, root cause analysis, and verification of effectiveness

Miami/Fort Lauderdale Area

• Ensure complete, accurate and timely reporting of MDR/vigilance data as required by regulatory agencies
• Experience with Code of Federal Regulations 21 CFR Part 820
• Directly working with Failure Analysis team and CAPA process
• Evaluate incoming field reports, product returns and product analysis results for Medtronic products as necessary to determine MDR
• Generate medical device rationale or Medical Device Report for all product complaints
• Provide input on internal system and methods to maintain MDR/vigilance compliance and support post-market surveillance