India Principal Regulatory Associate
Core
Lead regulatory strategy, submissions, and policy initiatives for Apple Health products in India and surrounding geographies to obtain approvals for new technologies.
Role type
Principal Regulatory Affairs Associate (Medical Devices)
Builds
Regulatory plans and submissions for Class A, B, and C medical devices and Software as a Medical Device (SaMD)
Domain
Healthcare / Medical Devices / Regulatory Affairs
Required skills
Medical device regulatory strategy, CDSCO regulations expertise, SaMD and algorithm-based product regulation, regulatory filing preparation, policy advocacy, risk assessment for regulatory plans
Preferred skills
EU MDR experience, global regulatory strategy, autonomous goal setting, cross-functional partnership with engineering, global regulatory requirement determination
Technologies
None stated
Responsibilities
Represent RA/QA team on regulatory submissions and policy initiatives, develop solutions to regulatory challenges, assess regulatory impact for new/modified products, prepare regulatory filings including pre-submissions and SEC meetings, craft policy and advocacy positions
Seniority
Principal, hands-on IC with strategic leadership
