Job Summary
The Director, Regulatory Affairs-JAPAC MedTech serves as a strategic regulatory leader and trusted advisor to medical technology clients across Japan and the Asia-Pacific region. This client-facing role is responsible for developing and leading regulatory strategies that support product development, market access, and commercialization for medical devices, diagnostics, digital health technologies, software as a medical device (SaMD), and combination products.
The Director will lead complex regional and global regulatory programs, provide expert regulatory consulting, build strong client relationships, and support business growth initiatives. This individual will collaborate with cross-functional teams and senior stakeholders to deliver high-quality regulatory solutions that help clients successfully navigate evolving global regulatory environments.
Job Responsibilities
- Provide strategic regulatory guidance and consulting to MedTech clients across Japan and the Asia-Pacific region.
- Develop and execute regulatory strategies for product registrations, market access, lifecycle management, and compliance initiatives.
- Lead complex regulatory programs, including multi-country submissions, global registration strategies, and U.S. FDA bridging activities.
- Serve as a trusted advisor to senior client stakeholders, providing regulatory leadership and risk-based recommendations.
- Direct large-scale regulatory projects, ensuring timely delivery, quality execution, effective resource management, and budget oversight.
- Lead interactions with regulatory authorities and support regulatory inspections, audits, and compliance activities.
- Partner with commercial and account teams to identify new business opportunities, support proposal development, and participate in client presentations and bid defenses.
- Drive operational excellence through continuous improvement of regulatory processes, tools, and delivery models.
- Mentor and develop regulatory professionals, fostering collaboration, knowledge sharing, and team growth.
- Represent IQVIA at industry conferences, professional forums, and client meetings through thought leadership and regulatory expertise.
Job Qualifications
Required Education
- Bachelor's degree in Life Sciences, Pharmacy, Biomedical Engineering, Regulatory Affairs, Engineering, or a related discipline.
- Advanced degree (Master's, MBA, or equivalent) and/or RAC certification preferred.
Required Experience
- 12+ years of Regulatory Affairs experience within the medical device, diagnostics, digital health, biotechnology, or broader healthcare industry.
- Significant experience supporting Japan regulatory activities and broader Asia-Pacific regulatory programs.
- Proven success leading complex regulatory projects, global submissions, and multi-country regulatory strategies.
- Experience working directly with health authorities and senior client stakeholders.
- Consulting or professional services experience strongly preferred.
Knowledge, Skills, and Abilities
- Deep knowledge of global medical device and diagnostic regulatory requirements, including PMDA, FDA, TGA, NMPA, MFDS, HSA, and other regional regulatory frameworks.
- Strong understanding of quality systems, clinical evidence requirements, risk management, and post-market regulatory obligations.
- Demonstrated expertise in regulatory strategy development for innovative technologies, including digital health and software-based medical products.
- Excellent leadership, stakeholder management, communication, presentation, and influencing skills.
- Strong business acumen with the ability to identify opportunities, solve complex regulatory challenges, and drive client success.
- Ability to lead cross-functional and geographically dispersed teams in a fast-paced, global environment.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.