Senior Regulatory Engineering Program Manager - Health/Product Integrity

Cupertino, California, United States

Hardware

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 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!

Description

We are looking for a 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:

  1. Advocate our approach to external stakeholders and policymakers while partnering with our Health organization.
  2. 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.
  3. 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.

Minimum Qualifications

  1. Bachelor's degree in an engineering discipline or equivalent.
  2. 5+ years of relevant Medical device / Health experience.
  3. Demonstrated track record in regulatory advocacy and medical device test protocol.
  4. Ability to guide and influence cross-functional teams, managing stakeholder expectations and fostering team collaboration.
  5. Strong verbal, written, and presentation skills to clearly organize and convey information across functions and levels.
  6. Excellent organizational, interpersonal, presentation, and communication skills.
  7. Eager to learn and be part of a team.
  8. Willingness and ability to travel internationally.

Key Qualifications

Preferred Qualifications

  1. MSME/MSEE/MSCE or MBA preferred, but not required.
  2. Working knowledge of medical device hardware, testing, and manufacturing processes.
  3. Technical project/product management experience.
  4. Experience with FDA, European Medicines Agency (EMA), or other global medical / health regulatory organizations.
  5. Understanding and working knowledge of ISO Medical Device Standards.

Education & Experience

Additional Requirements

Pay & Benefits

At Apple, base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The base pay range for this role is between $195,500 and $293,800, and your base pay will depend on your skills, qualifications, experience, and location. Apple employees also have the opportunity to become an Apple shareholder through participation in Apple’s discretionary employee stock programs. Apple employees are eligible for discretionary restricted stock unit awards and can purchase Apple stock at a discount if voluntarily participating in Apple’s Employee Stock Purchase Plan. You’ll also receive benefits including: Comprehensive medical and dental coverage, retirement benefits, a range of discounted products and free services, and for formal education related to advancing your career at Apple, reimbursement for certain educational expenses — including tuition. Additionally, this role might be eligible for discretionary bonuses or commission payments as well as relocation. Learn more about Apple Benefits.

Apple is an equal opportunity employer that is committed to inclusion and diversity. We take affirmative action to ensure equal opportunity for all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, Veteran status, or other legally protected characteristics.

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