The Program Manager's responsibilities include providing comprehensive support for global medical device submissions, product launches, design changes, medical device policy interactions, and cross-regional health initiatives, with a focus in China and APAC.
Minimum Qualifications
Bachelor's degree, preferably in engineering, science, business or equivalent field
8+ years of program/project management experience in a regulated industry, preferably in medical devices and/or digital health
Solid understanding of medical device regulatory and policy processes for different device classes, with familiarity across China and APAC markets
Experience building and managing relationships with Key Opinion Leaders, clinical institutions, or scientific advisory networks in support of medical device programs, ideally within China and APAC
Demonstrated experience planning and executing engagements, events, or partnership programs with external stakeholders in a medical device context
Proven track record of driving medical device regulatory submissions and launches with multi-disciplinary teams
Outstanding communication and organizational skills. Ability to optimally manage multiple projects simultaneously
Excellent analytical and problem-solving capabilities, with a keen eye to detect and mitigate risks
Independent self-starter who thrives in ambiguous environments
Hands-on experience in the use of project management and reporting software
Preferred Qualifications
Master's degree, preferably in engineering, science, business or equivalent field
10+ years of program/project management experience in a regulated industry, preferably in medical device, clinical studies, and/or digital health
Established network of China and APAC KOLs, clinical partners, or medical device regulatory contacts
Experience planning and hosting advisory boards, conferences, or regional stakeholder events focused on medical device policy
Track record of developing and managing strategic partnerships with clinical, academic, or industry organizations in the medical device space
Proven track record of driving quality system updates and medical device regulator engagements
Experience coordinating regional advisory boards, clinical partnerships, or scientific engagement programs
Experience with implementation of tools and systems for process management
Requires travel