Healthcare Compliance Attorney

Santa Clara Valley (Cupertino), California, United States
Corporate Functions

Summary

Posted:
Weekly Hours: 40
Role Number:200145446
We are seeking a dedicated and diligent professional to serve as the leader of Apple’s healthcare compliance function! Responsibilities include implementing and directing quality and robust research, as well as, running our medical device compliance program for the organization globally. The position includes responsibility for investigation and resolution of compliance issues, development and maintenance of policies and procedures, providing regulatory guidance and advice on compliance matters, conducting or coordinating training and education on research compliance, and working closely with the Head of Human Subjects Review Board and researchers and developers, as well as the broader Compliance organization within Apple.

Key Qualifications

  • Extensive knowledge of state and federal research and/or medical device compliance requirements, including emerging trends and issues
  • Experience defining, drafting and implementing policies and procedures and training, preferably research or medical device related
  • Ability to work independently with minimal supervision and collaboratively as a teammate in a fast paced work environment
  • Experience with leading organizational change as necessary to establish and implement processes
  • Ability to get results in diverse, fast paced environments
  • Strong organizational skills, with a keen eye for details
  • Excellent oral and written communication skills
  • Experience interacting with senior management
  • Standout colleague with ability to partner at all levels of the organization

Description

Defining and implementing a robust and highly visible medical device and research compliance program within Apple Developing and maintaining appropriate policies and procedures, guidance documents and training related to research within Apple, including identifying and tracking conflicts of interest for the review board members Acts as clinical compliance officer for external studies Acts as additional person responsible for regulatory compliance, pursuant to the EU Medical Device Regulations Responsible for education and compliance requirements for the Sunshine Act and similar transparency reporting requirements globally Responsible for global compliance issues related to distributing hardware with regulated software Monitoring and analyzing existing and new legislation, federal and international regulations, and guidance documents to stay informed of research related requirements Regularly providing training and guidance to research and development teams, internal review boards and regulatory teams within Apple

Education & Experience

J.D.

Additional Requirements

  • International experience a plus