Regulatory Affairs Manager

• Aug 2022 - Present

Regulatory Affairs Specialist II

• Nov 2021 - Jul 2022

1) Drafted 510(k)'s and responses to associated holds, pre-submissions, regulatory strategies, and provided guidance to clients on next steps for regulatory submissions 2) Provided regulatory and technical expertise to clients regarding electrical safety, electromagnetic compatibility, and software development 3) Drafted labeling include primary packaging labeling and instructions for use for clients that met regulatory requirements and marketing needs 4) Led creation of IEC 62304… Show more 1) Drafted 510(k)'s and responses to associated holds, pre-submissions, regulatory strategies, and provided guidance to clients on next steps for regulatory submissions 2) Provided regulatory and technical expertise to clients regarding electrical safety, electromagnetic compatibility, and software development 3) Drafted labeling include primary packaging labeling and instructions for use for clients that met regulatory requirements and marketing needs 4) Led creation of IEC 62304 software development process and associated templates for configuration management, software development, safety class and level of concern, and requirement, architecture, and detailed design specifications 5) Trained team members on software development processes and needs for design history file and 510(k) submissions

Lead Product Development Engineer

• Jul 2020 - Nov 2021

1) Key contributor to drafting company-wide templates for design control documentation 2) Acted as technical team lead for several projects, coordinating work amongst team members and testing labs, and keeping projects on schedule having led four products to commercial launch and many others through preceding design phases 3) Lead the quality review for implementation of two manufacturing lines including coordinating drafting of work instructions, employee training, IQ/OQ/PQ protocols… Show more 1) Key contributor to drafting company-wide templates for design control documentation 2) Acted as technical team lead for several projects, coordinating work amongst team members and testing labs, and keeping projects on schedule having led four products to commercial launch and many others through preceding design phases 3) Lead the quality review for implementation of two manufacturing lines including coordinating drafting of work instructions, employee training, IQ/OQ/PQ protocols and reports, and production SW validation 4) Lead the drafting of ISO 13485 compliant Design History File (DHF) documentation for 5+ projects including, but not limited to, Product Development Plans (PDPs), Design Requirement Traceability Matrices (DRTMs), Verification/Validation Plans and Reports, Design Transfer Plans, and Device Master Records (DMRs) 5) Assisted in the drafting of 510(k) regulatory submissions leading the drafting of sections related to device description, software, and non-clinical performance testing 6) Provided guidance to clients on best practices for ISO 13485 and design control practices 7) Lead 10+ phase review and technical design review meetings required per ISO 13485 Design Control procedures ranging from initial design freeze through design transfer

Product Development Engineer

• Jun 2019 - Jul 2020

1) Coordinated testing with 3rd party labs for shelf-life expansion, mechanical testing, and IEC electrical safety testing 2) Performed and coordinated activities related to CAPAs, manufacturing waivers, and other ISO 13485 quality activities 3) Acted as technical team member for multiple projects, coordinating work among team members, and keeping projects on schedule 4) Drafted ISO 13485 compliant Design History File (DHF) documentation 5) Assisted in the drafting of 510(k)… Show more 1) Coordinated testing with 3rd party labs for shelf-life expansion, mechanical testing, and IEC electrical safety testing 2) Performed and coordinated activities related to CAPAs, manufacturing waivers, and other ISO 13485 quality activities 3) Acted as technical team member for multiple projects, coordinating work among team members, and keeping projects on schedule 4) Drafted ISO 13485 compliant Design History File (DHF) documentation 5) Assisted in the drafting of 510(k) regulatory submissions 6) Participated in phase review and technical design review meetings

Junior Product Development Engineer

• Jul 2018 - Jun 2019

1) Acted as technical team member for multiple projects having helped bring an electromechanical device line extension project to product launch and several others through preceding design phases 2) Drafted ISO 13485 compliant Design History File (DHF) documentation 3) Participated in phase review and technical design review meetings required per ISO 13485 Design Control regulations 4) Performed Risk Management File (RMF) activities including drafting risk management plans, design… Show more 1) Acted as technical team member for multiple projects having helped bring an electromechanical device line extension project to product launch and several others through preceding design phases 2) Drafted ISO 13485 compliant Design History File (DHF) documentation 3) Participated in phase review and technical design review meetings required per ISO 13485 Design Control regulations 4) Performed Risk Management File (RMF) activities including drafting risk management plans, design FMEAs, and reports documenting completion of annual post-market surveillance activities

Undergraduate Teaching Assistant

• Aug 2015 - Dec 2016

Graded homework and exams for an undergraduate electrical circuit analysis course; tutored students and provided assistance to those struggling with material; held regular office hours; held lectures and substituted for instructor as requested Graded homework and exams for an undergraduate electrical circuit analysis course; tutored students and provided assistance to those struggling with material; held regular office hours; held lectures and substituted for instructor as requested