drjobs Principal International Regulatory Affairs Associate

Principal International Regulatory Affairs Associate

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1 Vacancy
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Job Location drjobs

Cupertino, CA - USA

Monthly Salary drjobs

USD 174900 - 291400

Vacancy

1 Vacancy

Job Description

You will represent the International Regulatory Affairs team on a high-impact collaborative partnership with regional RA experts you will develop articulate and drive the global regulatory strategy for innovative pipeline features. You will proactively address regulatory challenges make informed decisions and communicate appropriate regulatory actions. Additionally you will develop engagement strategies with global health authorities to facilitate the regulatory pathway and support launch plans as needed. Key responsibilities include: Develop and implement comprehensive global regulatory strategies for Apple Health features Collaborate closely with multi-functional teams across Apple to communicate regulatory plans clearly and maintain alignment throughout development Lead and handle regulatory authority interactions and negotiations advocating for Apples position while ensuring compliance and timely approvals Identify potential regulatory risks and opportunities early by engaging with global regulatory landscapes and advise internal teams to inform product development and strategy Partner with internal partners and external bodies to influence and shape emerging regulations and guidances that impact Apple Health is site-based role.


  • Bachelors degree or equivalent in science or engineering
  • 10 years of experience in regulatory affairs
  • Regulatory expertise in one or more key markets such as EU/UK China or Japan
  • Proven ability to work autonomously and drive established goals and initiatives with minimal supervision
  • Executive presence and poise demonstrated through a strong track record of positively influencing decisions and cross-functional teams


  • Masters / PhD / post-secondary education preferred
  • Experience working with the SaMD product and wearable technology
  • Experience navigating regulatory environment in emerging markets
  • Excellent verbal and written communication skills

Required Experience:

Staff IC

Employment Type

Intern

Company Industry

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