India Principal Regulatory Associate
Core
Lead regulatory strategy, submissions, and policy initiatives for Apple's health products (Class A, B, C devices and SaMD) in India and surrounding geographies.
Role type
Principal Regulatory Affairs Associate (Health/Medical Devices)
Builds
Regulatory approvals and policy frameworks for new health technologies
Domain
Medical Devices / Software as a Medical Device (SaMD) / Healthcare
Required skills
Medical device regulatory strategy, CDSCO regulations, SaMD/algorithm/sensor-based product compliance, regulatory filing preparation, Subject Expert Committee (SEC) meeting management, policy advocacy, risk assessment, cross-functional partnership with engineering
Preferred skills
EU MDR experience, global regulatory strategy, autonomous goal execution, global team collaboration, determination of global regulatory requirements
Technologies
None explicitly listed beyond product types (SaMD, sensors, algorithms)
Responsibilities
Represent RA/QA team on regulatory submissions and policy initiatives, develop solutions to regulatory challenges, assess regulatory impact for new/modified products, execute clear regulatory plans, craft policy and advocacy positions
Seniority
Principal, strategic leadership with hands-on execution
