Regulatory Affairs Associate (Principal) - Medical Devices
Core
Lead regulatory strategy and submissions for Apple Health products to obtain global approvals for new medical device technologies.
Role type
Principal Regulatory Affairs Associate (Medical Devices)
Builds
Regulatory plans and filings for Class I, II, and III medical devices, including Software as a Medical Device (SaMD).
Domain
Medical Devices / Regulatory Affairs
Required skills
US FDA interaction, regulatory filings (510(k), De Novo, IDE), US regulations for Class I/II/III devices, SaMD strategy, clinical study design integration, risk mitigation, global regulatory requirements.
Preferred skills
EU MDR experience, autonomous goal setting, cross-functional partnership with engineering, global regulatory strategy.
Technologies
None stated
Responsibilities
Represent RA/QA on regulatory initiative and new product development teams; assess regulatory impact for new/modified devices; develop and execute clear regulatory plans in the US and globally; prepare regulatory filings including pre-submissions, 510(k)s, De Novos, and IDEs.
Seniority
Principal, hands-on IC with strategic oversight
