Apple AR/VR Job | Senior Regulatory Engineering Program Manager - Health/Product Integrity
Job（岗位）: Senior Regulatory Engineering Program Manager - Health/Product Integrity
Citys（岗位城市）: Cupertino, California, United States
Date（发布日期）: 2024-12-10
Summary（岗位介绍）
Imagine what you could do here at Apple, new ideas have a way of becoming great products, services, and customer experiences very quickly. Bring passion and dedication to your job and there's no telling what you could accomplish.
At Apple, we deliver products, technologies, and services to inspire creativity and enrich lives. Apple has become one of the most recognized and trusted brands in the world. As such, we hold ourselves to the highest standards to maintain public and employee trust by ensuring regulatory compliance.
Apple's growing Product Integrity Strategic Engineering Program Management (EPM) group. Our team is looking for a forward-thinking, hard-working, and motivated EPM to partner with Apple’s Health Team to support regulatory deliverables and engagement. If you are passionate about customer experience and thrive working alongside brilliant individuals, come join our amazing team!
Qualifications（岗位要求）
Bachelors degree in an engineering discipline or equivalent
5+ years of relevant Medical device / Health experience
Demonstrated track record in regulatory advocacy and medical device test protocol
Ability to guide and influence cross-functional teams, managing stakeholder expectations and fostering team collaboration.
Strong verbal, written, and presentation skills to clearly organize and convey information across functions and levels.
Excellent organizational, interpersonal, presentation, and communication skills
Eager to learn and be part of a team
Willingness and ability to travel internationally
Description（岗位职责）
We are looking for self-motivated, fast learner with excellent communication skills who is eager to collaborate with multiple internal and external teams on Health regulatory matters to enable Apple’s Health Product Strategy. The ideal candidate will establish strong relationships with partners, understand their goals and objectives, and help navigate conflicts and competing priorities with diplomacy and data-driven insights.
In this role you will:
Advocate our approach to external stakeholders and policymakers while partnering with our Health organization.
Drive program objectives and schedules by working closely with highly skilled Apple engineers, architects, operations teams, product design teams, Health Professionals as well as external partners and regulators.
Play a critical role in orchestrating long-term changes in Health regulations and policy, guiding teams to achieve favorable outcomes in regulatory proceedings within international and national regulatory bodies, all while remaining flexible and calm in the face of uncertainty.
Additional Requirements（额外要求）
MSME/MSEE/MSCE or MBA preferred, but not required
Working knowledge of medical device hardware, testing, and manufacturing processes
Technical project/product management experience
Experience with FDA, European Medicines Agency (EMA) or other global medical / health regulatory organizations
Understanding and working knowledge of ISO Medical Device Standards
