Senior Manager Regulatory Affairs - Philips Healthcare - Remote
(2023-07)
Direct and oversee complex, cross-functional SRC programs, ensuring strategic alignment and execution.
- Lead enterprise regulatory strategy across a global product portfolio, ensuring sustained compliance and uninterrupted market access across U.S., EU, APAC, and LATAM
- Advise executive leadership on regulatory risk, innovation strategy, and portfolio planning, embedding regulatory insights into business growth initiatives
- Direct and develop a global regulatory organization of 12, driving capability expansion, operational rigor, and execution excellence
- Reduced regulatory response timelines by 30% by implementing advanced regulatory intelligence and proactive monitoring frameworks
- Partner with R&D and Quality to transform submission processes, accelerating speed-to-market and reducing rework across the enterprise
- Champion global UDI/EUDAMED strategy and data integrity initiatives, strengthening regulatory infrastructure and enterprise readiness
Regulatory Affairs Consultant - US Tech Solution – Baxter Healthcare - Remote
(2022-05 - 2023-04)
Support global product UDI Regulatory Compliance throughout the product lifecycle
- Led global UDI regulatory compliance across the product lifecycle, ensuring alignment with evolving requirements in U.S., China, Europe, South Korea, and Saudi Arabia
- Drove governance and data integrity for global UDI databases, ensuring accuracy and readiness for global submissions
- Orchestrated cross-functional collaboration across engineering, data management, and product teams to ensure seamless UDI integration and lifecycle management
Global Manager, QARA Project Management Office (Consultant) - Zimmer Biomet - Remote
(2021-07 - 2022-10)
Directed a global PMO supporting enterprise Quality and Regulatory strategy, ensuring disciplined execution of high-impact programs.
- Led a team of project managers to deliver global QMS harmonization, regulatory readiness, and capability-building initiatives
- Chaired governance forums and executive steering committees, driving transparency, risk mitigation, and alignment on program outcomes
- Established global training frameworks strengthening regulatory understanding and cross-functional execution across regions
- Acted as site Change Ambassador for EUDAMED-PLM BUDI/DI (Basic UDI/DI), leading stakeholder alignment and adoption across impacted functions
- Designed and implemented performance measurement strategies to assess program effectiveness and drive continuous improvement
- Served as site and business process owner for FDA UDI Global QA/RA Harmonization and EUDAMED initiatives, ensuring enterprise-wide compliance and seamless integration across global regulatory systems
Quality Assurance Project Manager - Cognate Bioservices - Memphis, TN
(2017-08 - 2018-07)
Led global QMS harmonization, training optimization, and quality systems simplification across 8+ sites.
- Directed complaint handling, CAPA, nonconformance, and audit readiness programs, improving compliance and cycle times by 25–30%
- Represented organizations during audits and client visits, strengthening regulatory confidence and quality system transparency
- Implemented PLM systems (Pilgrim, Windchill), supporting data migration of 15,000+ records with 99.5% accuracy
Senior Quality System Specialist - Medtronic - Memphis, TN
(2014-04 - 2016-09)
Oversaw the implementation of global training project and global quality system harmonization project to reduce the number of redundant work instructions and procedures
- Directed quality initiatives across eight spinal sites, including quality systems simplification and enterprise training optimization to strengthen global consistency and compliance
- Represented the site within the Global QMS Implementation Council, contributing to the Global Quality Integration Team and Global Training Sub-Council to drive harmonization efforts
- Led Management Review processes by consolidating and presenting quality performance metrics to executive leadership, enabling data-driven decision-making
- Redesigned the nonconformance and audit process flow, strengthening root cause analysis and improving effectiveness of corrective and preventive actions (CAPA)
- Oversaw governance of quality documentation lifecycle (draft, review, approval, communication, and training), ensuring alignment with regulatory and internal standards
- Developed and maintained quality policies, procedures, work instructions, and forms to ensure sustained compliance with regulatory requirements and enterprise standards
- Served as Training Administrator for the Global Spine Division, overseeing training compliance, tracking, and execution across the organization
- Led the Spinal Training Review Board, providing strategic direction and oversight for local and global training alignment
- Supported development of departmental eLearning programs and training matrices to improve capability building and standardization
- Established and led global change management framework to capture stakeholder input, user requirements, and functional specifications for quality system initiatives
- Provided cross-functional support for local and global technical and business processes, driving continuous quality improvement and operational excellence
Consumer Affairs (Consultant) - Medtronic - Memphis, TN
(2014-01 - 2014-04)
- Monitored incoming complaints for increasing trends and alert management when a product issue was emerging
- Participated in monthly tracking and trending meetings - provide input on early trends that may not yet be reflected in the data
- Ensured that customer complaints were reviewed in a timely manner and given to the medical events group as necessary to meet reporting regulations
- Ensured that product quality issues were identified as early as possible and remedied through the corrective and preventive action system
- Identified and recruited staffing / resources to support complaint handling activities and on-market support for multiple product lines deemed critical to success of financial performance for the Division
- Identified and implemented the organizational structure necessary to achieve business objectives and QA compliance within the complaint handling organization
- Ensured complaints were evaluated against criteria for potentially reportable events and elevated to the medical events group as necessary to meet worldwide medical event reporting requirements
Senior Quality Compliance Specialist - Bioventus (previously Smith+Nephew) - Memphis, TN
(2012-11 - 2014-01)
Oversaw the implementation of the PLM (Pilgrim), management review process, and audit site audit program
- Supervised day-to-day activities for the employees
- Provided oversight of investigation activities, generating complaint summaries and followed up interactions with external patient/customer to provide direct feedback either via phone call, email or letter
- Supported the organization by managing a compliant and efficient Complaint Handling system that includes ensuring accurate, timely and thorough investigations/summaries, and effective customer interactions, feedback and issue solving
- Prepared monthly quality reports outlining product deficiencies and trend analysis while providing recommendation for change to the IFU's
- Audited and approved cases to ensure compliance with the company's Quality Management System and FDA requirements
- Ensured the Complaint Process is end-to-end customer focused by developing training modules to promote awareness and acknowledgement of compliance and the complaint reporting process
- Compiled and summarized all investigation activities received from customers and delivered appropriate written, verbal or in person communication back to external customer, when appropriate
- Interfaced with customer service management team to ensure the complaints received are handled by the complaint handling procedure
- Ensured SOP's and WI reflected a robust complaint handling process
- Identified and implemented effective complaint investigation strategies to ensure appropriate steps are taken and addressed during the complaint handling and investigation processes
