• Supported the Regulatory and Quality needs of several North American MedTech companies seeking clearance in the US, EU and Canada
• Authored and presented the first white paper on Digital Health in Taiwan, supporting Sanofi Taiwan and Health2Sync in their conversations with Taiwan FDA and the National Health Insurance Agency on local and global regulatory challenges and ways forward
• Delivered multiple training sessions and topical presentations on medical device and digital health regulations at the Biomedical Translation Research Centre (BioTrec), ITRI (Taiwan's largest R&D institution) in collaboration with BioMed Taiwan (Biomedical Industry Association), ITRI College (educational arm of ITRI), and the European Chamber of Commerce in Taipei

Remote (HQ in Montreal) 01/2022 - 01/2023
• Built regulatory strategy for, project-managed and delivered EU-MDR technical documentation submission for a Class IIb device family (eye-drops)

• Provided guidance on regulatory strategy to obtain Health Canada and CE mark approvals
• Participated in the ISO13485:2016 and MDSAP certification audit

• Recruited and onboarded the entire team of Quality Operations (7 direct reports and 4 dotted lines)
• Successfully integrated the Stryker Quality System in record time of four months (instead of 2 years)
• Implemented a PQM (Product Quality Management) system for non-conformance handling
• Organized a Quality Day with focus on manufacturing associates to introduce key Quality concepts and expectations

• Obtained system approval and critical component clearance in several international markets, including China and Japan
• Closed approximately four years of technical change regulatory assessment backlog in six months
• Systematized and streamlined the regulatory aspect of the international business unit, including labelling
• Successfully led the second phase of integration to the Stryker business, completing re-registrations with local European authorities, labelling updates and other remediation requirements in a three-month period

• Successful and on-time delivery of annual steam sterilizer re-validation through improved protocols and careful planning around production schedules
• Developed and coordinated execution of the OQ/PQ (temperature mapping) protocol for new chemical sterilization equipment
• Proposed a streamlining of moist heat sterilization process expected to reduce autoclave use time by 300%

• Assessed for regulatory impact and documented a three-year backlog of technical changes in four months
• Developed global regulatory strategy for a change in chemical sterilant and critical sterilization equipment
• Prepared and obtained approval for post-market changes in the US (30-Day notice and annual reports) and Europe

• Enabled launch of new product lines in Asia Pacific, generating 25% market share growth in FY12/13 for Clairol Professional in China
• Built regulatory strategy for a production site relocation from Europe to Thailand, with no impact on compliance
• Led regulatory strategy for paraben-free reformulations (due to ban in Europe), ensuring 100% compliance and no interruption to business