Project Manager, Regulatory Affairs Health Special Projects

Santa Clara Valley (Cupertino), California, United States
Software and Services

Summary

Posted: Nov 14, 2018
Weekly Hours: 40
Role Number: 200005274
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 manage 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 Regulatory Affairs with at least 3 in a Project management role.
  • Experience working with software engineering projects
  • You've worked with a digital health product or medical device Class II with a strong software element to the product.
  • Excellent communication and organizational skills
  • Excellent analytical and problem-solving abilities
  • You are uncommonly detail oriented.
  • Working knowledge of regulatory submission requirements for FDA Class II medical devices in both the US and Internationally
  • You keep up to date on regulatory requirements, especially FDA and EU
  • You have the ability to detect and mitigate risk

Description

The Project Manager will provide regulatory support for both domestic and international product submissions. This person will work hand in hand with the regulatory team and may provide hands-on individual contribution to meet RA team’s objectives. You'll 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. 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: Oversee activities and resolve problems for Regulatory and project team Coordinate with international regulatory team members on product changes and regulatory notification /approval requirements Build and update RA responsible quality system procedures as required (i.e. SQP/SOP’s)

Education & Experience

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

Additional Requirements

  • Experience with FDA/GMP/Quality Systems per ISO 13485 requirements