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• Experience with Complaint Handling Process, from intake to submission• Experience filing MDR’s to EU, South Africa, Canada, Brazil, and Japan

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• Proactively creating course of action with our incoming complaint matters• Assist with remediation action planning and execution• Facilitates the timely initiation of complaints and closure of complaint investigations Develop, prepare, and analyze trend reports for Complaints/ MDR monthly or quarterly as required• Evaluate complaints to determine whether an investigation is necessary and if Medical Device Reporting (MDR) is necessary in accordance with 21 CFR Part 820