Copenhagen, Capital Region of Denmark, Denmark
I am a Quality and Regulatory Affairs professional with more than 20 years of international experience within the pharmaceutical, biotechnology, and medical device industries. Throughout my career, I have held specialist, management, and senior leadership roles, leading global quality initiatives in highly regulated and complex environments. My expertise covers the development, implementation, and continuous improvement of Quality Management Systems (QMS), including CAPA, complaint handling, change control, audit readiness, supplier quality, validation, and compliance excellence. I have extensive hands-on experience with ISO 13485, MDR, FDA 21 CFR Part 820, MDSAP, ISO 14971, EU-GMP, and other global regulatory frameworks. In recent years, I have focused strongly on driving quality transformation, operational excellence, and cross-functional collaboration across global organizations. I thrive in environments where quality, business strategy, innovation, and people leadership intersect. Alongside my corporate career, I am also the founder and leader of a Vietnamese martial arts organization, reflecting my strong interest in discipline, resilience, leadership development, and mental strength. I value multicultural collaboration and believe sustainable results are created through trust, accountability, and continuous learning. I am passionate about building compliant, efficient, and future-oriented quality organizations that support both patient safety and business growth.
Led the end-to-end planning, execution, and monitoring of Regulatory Affairs projects, ensuring alignment with defined deliverables, timelines, and budgets. Developed detailed project plans, allocated resources, and coordinated cross-functional teams to achieve project milestones. Collaborated with senior management to review progress, mitigate risks, and implement schedule adjustments. Maintained rigorous documentation and quality standards, provided regular stakeholder updates, and generated reports for executive review. Held decision-making authority within project scope, with escalation protocols in place for budget or resource deviations.
Senior Technical Project Manager, Global Regulatory Affairs, Continuous Improvements Management. MDR Project Management.
Senior Project Technical Manager. Ensuring on-time cross functional knowledge sharing and activities management. Including following up and closure of committed tasks execution. Identifying and determining CTQ tasks herby mitigations actions. Keeping the team accountable through regular Debriefings. Striving to do the impossible to support a Team Winning Culture based on Committed Accountability and Responsibility built on Trust.
Ensuring Our Hearing & Balance Products are safe and effective for our Users and Patients
Complaint and Vigilance System
- QA of Qualifications, Changes, Users Access review, Configuration Management - Change Management - Quality Issues Management (nonconformities) - Leading Quality Audits - Quality Consultancy - Quality training and awareness