Regulatory Project Manager - OUS

Cupertino, CA 95014
  • Job Code
    200143471
Summary

Summary

Posted: Jun 22, 2020

Weekly Hours: 40

Role Number:200143471

Our ever-evolving suite of Heath and Wellness products for iPhone and Watch are helping our users live more act...Summary

Summary

Posted: Jun 22, 2020

Weekly Hours: 40

Role Number:200143471

Our ever-evolving suite of Heath and Wellness products for iPhone and Watch are helping our users live more active, healthier lives. Be ready to make something great when you come here. Dynamic, inspiring people and innovative, industry-defining technologies are the norm at Apple. The people who work here have reinvented and defined entire industries with our products and services. The same dedication to innovation also applies to our business practices - strengthening our commitment to leave the world better than we found it. Do you want to help deliver the next amazing Apple product?

Project Managers (PMs) are responsible for leading a broad multi-functional team in developing projects across the Engineering, Regulatory, and Clinical organizations. In this critical, highly visible role, you will lead projects requiring regulatory approval to help launch ground breaking technologies for Apple. Our teams feature a collaborative environment with creative people who care deeply about getting great products in the hands of our users. Are you passionate about truly changing health? Come, join us in crafting solutions the world doesn't know of yet!

Key Qualifications

  • 5+ years of experience in a Project Management role with a preferred background in Regulatory Affairs, Quality Assurance, or Clinical Affairs.
  • Proven success driving multiple complex projects and/or global product launches simultaneously.
  • Experience working with and managing vendors.
  • Flexible mindset; able and willing to change direction quickly.

Description

The Project Manager will provide regulatory support for both domestic and international product submissions, approvals, and launch readiness. You will work hand in hand with the regulatory team and may provide hands-on individual contribution to meet regulatory team's objectives. You will be responsible for tracking project submission deliverables and provide support for the US and OUS submissions by coordinating with various team members to obtain necessary documents required for timely submissions. You will collaborate closely with multiple cross-functional teams to drive product launch readiness internationally. In addition, you will drive day-to day program activities, generate and own monthly Global Regulatory submission and approval score cards, and conduct risk assessments to meet overall program objectives for development projects.

General

RESPONSIBILITIES:

- Lead all aspects of international product launch readiness for Apple's Health products.
- Coordinate activities and problem solve for Regulatory and project team.
- Coordinate regulatory submissions and approvals internationally.
- Coordinate with international regulatory team members on product changes and regulatory notification/approval requirements.
- Build and update regulatory responsible quality system procedures as required (i.e. SQP/SOPs).

Education & Experience

BS/MS in Engineering, Biomedical Science or equivalent science degree.

Additional Requirements

  • - Working knowledge of regulatory submission requirements for FDA Class II medical devices in both the US and internationally preferred
  • - Experience with a digital health products or Class II medical devices with a strong software element to the product.
  • - Experience with FDA/GMP/Quality Systems per ISO 13485 requirements
  • - Highly organized and hyper-attentive to detail.
  • - Thrives in a fast-paced environment.
  • - Comfortable receiving direction from multiple people at once.
  • - Good at multi-tasking and prioritizing.
  • - Independent and self-motivated.
  • - Enjoys working with cross-functional groups.
  • - Excellent analytical and problem-solving abilities; comfortable entering data and organizing information.
  • - Ability to detect and mitigate risk.
  • - Excellent communication skills, both verbal and written.
  • Apple is an Equal Opportunity Employer that is committed to inclusion and diversity. We also take affirmative action to offer employment and advancement opportunities to all applicants, including minorities, women, protected veterans, and individuals with disabilities. Apple will not discriminate or retaliate against applicants who inquire about, disclose, or discuss their compensation or that of other applicants.


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Regulatory Project Manager - OUS

Apple, Inc.
Cupertino, CA 95014

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