Over 15 years’ experience in Regulatory Affairs and Quality Assurance in an FDA & ISO/MDSAP/EU regulated medical device environment. Strong background in Regulatory compliance, interpreting regulations and standards for robust work procedures. Operating as an RA/QA consultant committed to providing professional and reliable services, focused on meeting client’s needs and exceeding expectations.Areas of Expertise:• Transition to EU MDR 2017/745 - strategic planning, gap assessments and hands on remediation• Working knowledge of Technical Documentation development under EU MDR• Clinical Evaluation Plan and writing Clinical Evaluation Reports (CER’s) under EU MDR• Vigilance Reporting US, EU, and ROW• CE mark submissions/ TD Development for file review CE mark maintenance• Post Market Surveillance (PMS) Plan, Periodic Safety Update Report (PSUR) and Post-Market Clinical Follow-Up• UKCA marking, device registration and appointment of UKRP• Northern Ireland (NI) marking and AR• Swiss Importer and CH-REP• International Product Registrations• Risk Management ISO 14971:2019• Audit support for FDA, ISO/MDSAP/EU/Brazil External QMS audits• Audit Support for FDA/ISO/MDSAP/EU/Brazil External QMS Audits• Internal QMS Audits ISO 13485:2016• Customized work procedures