Responsible for the planning and execution of all medical device regulatoryand compliance activities, including completing regulatory submissions andcompliance assessments, and managing the Quality Management System

- Responsible for the planning and execution of all medical device regulatory and compliance activities, including completing regulatory submissions and compliance assessments, and managing the Quality Management System- As a member of the leadership team, develops high level regulatory strategies, accounting for business risk, budget, and company strategies, ensuring a high level of quality and patient safety- Represents Cerebra as their Quality Management Representative and their Privacy Officer- Manage the company-wide compliance with ISO 13485, MDSAP program, and Canada/USA medical device regulations- Compiled documentation and received device regulatory clearances in Canada and the US 510(k)- Worked with all departments to develop their processes and procedures, holding them accountable to their contributions to the quality of product, while maintaining the procedures and templates of the QMS- Eliminated numerous redundancies in the regulatory and compliance team- Replaced the electronic signature tool with an industry standard one- Implemented a privacy compliance program, complying with the US HIPAA and Canadian provincial PHIA regulations

- Responsible all of medical device regulatory and compliance activities, including completing regulatory submissions and compliance assessments, managing the Quality Management System, and developing strategies- Represented Arterys as their Quality Management Representative- Managed the compliance with ISO 13485 and medical device regulations in USA, Canada, EU, Brazil, Australia, UAE, Saudi Arabia, Israel- Compiled documentation and received device regulatory clearances in 6 countries, including two US 510(k) Class II clearances- Worked with all departments to develop their processes and procedures, holding them accountable to their contributions to the quality of product - Replaced an expensive and complicated document/record management system tool with a much simpler and free system- Removed gaps and received the MDSAP (Medical Device Single Audit Program) certificationImplemented the EU Medical Device Regulation and passed the technical file and clinical evaluation audits- Implemented a privacy and security compliance program, complying with ISO 27001 Information Security and EU GDPR; Received ISO 27001 certification

• Represented CSI as their Quality Management Representative• Implemented updated ISO 9001:2015 and ISO 13485:2016 standards, by determining and filling gaps in processes, while maintaining compliance• Analyzed and developed a plan to implement the new European Medical Device Regulation• Developed departmental budget and strategy information• Coordinated the implementation of AAMI TIR57: Security risk management for medical devices

• Managed the company-wide compliance with ISO 9001, ISO 13485, and the medical device regulations in USA, Canada, Europe, China, Japan, among others• Responsible for, or assisted with, medical device regulatory approval in over 7 countries, including a USA 510(k)• Audited internal processes as Lead Auditor; found non-conformances and coordinated corrective and preventive actions• Coordinated with teams to implement new or updated software ISO and IEC standards, such as IEC 62304 Medical Device Software Lifecycle • Championed process improvement initiatives within other departments• Prepared technical documentation for software release design history files and international regulatory submission certifications• Managed regulatory relationships with global distribution partners• Worked closely with the executive team on process matters applying to the overall business• Gathered metrics from all departments to determine trends associated with product quality and patient safety information• Initiated the company Employee Health & Saftey Committee and developed procedures to comply with Occupational Health & Safety legislation

• Passionately led and mentored the software testing/QA and deployment teams, consisting of twelve people and six contractors, including managing remote staff • Successfully mentored two technical people, helping them grow and evolve into effective independent team leaders• Championed new development and testing techniques, including working toward implementing the Agile Software Development Process• Devised test strategies by studying project objectives and timelines, estimating testing efforts and developing test schedules• Overhauled the R&D Software Development Process procedures to reduce confusion and increase the overall level of the quality of the product• Conducted reviews, inquiries, and audits to ensure defined procedures were being followed appropriately

• Led the R&D department, consisting of 5 people (draftsperson, electrical technologists, etc.) • Organized and directed team meetings and delegated responsibilities• Prioritized and managed R&D projects, from concept to full production• Managed interdepartmental communication• Participated in senior management meetings, providing technical advice to the CEO and CFO

• Created and executed x-ray lab tests to determine the effect of modifications to proprietary digital x-ray detectors• Developed new procedures to solve ongoing issues and prevent future problems• Supervised a junior research physicist and 3 summer students• Managed the company-wide radiation safety program

• Improved and verified sizing accuracy of in-line MFL (magnetic flux leakage) inspection analysis software through statistical analysis and neural network training (using Matlab), increasing the overall accuracy by 40%• Developed and tested software used to decrease time required to find and size corrosion defects in oil and gas pipelines by using filtering techniques and pattern recognition programming• Published numerous papers, presenting “The Use of Tri-Axial Sensors To Better Determine Defect Parameters From Magnetic Flux Leakage Signals” at the NACE (National Association of Corrosion Engineers) 2003 Conference