Janet Macones

Janet Macones has over 12 years of experience in the Regulatory Affairs Quality Assurance (RAQA) field. Janet began their career in 2008 as a Quality Compliance Consultant with Maetrics, LLC. From 2009 to 2011, they worked as a Global Regulatory Compliance Specialist with CooperVision. Janet then moved to ImmunoScience, Inc. as a Sr. Regulatory Affairs Quality Assurance from 2011 to 2013. In 2017, they joined Neozene, Inc. as a Senior RA QA. From 2018 to 2020, they worked as a Senior Quality Assurance Regulatory Affairs with MAETRICS. In 2020, they became the VP Risk Management & Policy at SolonTek Corporation. Currently, they are a Consultant RAQA at Macones, and will begin a new role as RAQA Consultant at RQM+ in 2022.

Janet Macones has an extensive education history. Janet has obtained certifications from the BSI British Standards Institution in ISO 13485:2016 Lead Auditor (TPECS) and ISO 19011:2018 Auditing Management Systems. Additionally, they obtained certifications from NSF International Public Health and Safety Organization in MDSAP EU MDR Regulations, Medical Device Regulatory Requirements - Australia, Medical Device Regulatory Requirements - Brazil, Medical Device Regulatory Requirements - Canada, Medical Device Regulatory Requirements - Japan, and Medical Device Regulatory Requirements United States. Janet also obtained certifications from BSI Quality Management Systems Exemplar Global in ISO 19011:2018 AU TL QMS Audit and from British Standards Institute Quality Management Systems Exemplar Global in ISO 13485:2016 AU TL QMS Auditor (TPECS). Janet Macones is currently studying ISO 21001 Foundations Information Technology Security from Advisera. Janet has also attended Ohlone College where they studied English Language and Literature, General Graphic Design, and Marketing, as well as Silicon Valley University where they studied Graphic Design and Desktop Publishing.