Job Details

Weekly Hours: 40

Role Number: 200650169-0836

Summary

Apple is where individual imaginations gather together, committing to the values that lead to great work. Every new product we build, service we create, or Apple Store experience we deliver is the result of us making each other’s ideas stronger. That happens because every one of us shares a belief that we can make something wonderful and share it with the world, changing lives for the better. It’s the diversity of our people and their thinking that inspires the innovation that runs through everything we do. When we bring everybody in, we can do the best work of our lives. Here, you’ll do more than join something — you’ll add something.

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.

Description

The ? Health group is looking for an International Quality and Regulatory Compliance Associate to support regulated medical device software compliance. If you are passionate about the health space and want to have an incredible impact here at Apple, this could be the role for you. We are an efficient organization who works closely together to establish relationships across multiple functional teams. We care deeply about getting amazing new products into our customers hands.

The International Quality and Regulatory Compliance Associate is part of the quality team supporting Apple’s medical products. The team is responsible for working closely with cross functional teams to ensure product conforms to specified requirements globally. The International Quality and Regulatory Compliance Associate drive the execution and implementation of OUS requirements.

This is a site-based role.

Minimum Qualifications

• B.S. ME/EE/BME/CS degree or equivalent in any engineering discipline

• 5+ years of experience on international/OUS/ROW medical device projects in either a quality or regulatory role

• Strong understanding of Quality Management Systems (QMS), ISO 13485, and international quality requirements

• Strong working knowledge of US, EU, APAC, LATAM, ASEAN and other global regulations that affect Class I, II and III devices

• Strong knowledge of and experience working with and implementing global regulations

• Strong analytical skills and the ability to conduct and document gap analyses

Preferred Qualifications

• Experience working on software medical device products within a quality or regulatory system.

• Experience identifying the need for Quality Improvement projects and implementing recommended enhancements to the QMS

• Proven background in being autonomous and being able to clearly work towards establish goals and initiatives with minimal oversight.

• Demonstrated competence in determination of appropriate global regulatory requirements for new products or product changes.

• Strong organizational and leadership skills.

• Excellent communication skills, both verbal and written. Ability to take initiative in an ambiguous and fast fast paced environment

• Strong organizational, time management, and influence skills

Apple is an equal opportunity employer that is committed to inclusion and diversity. We seek to promote 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. Learn more about your EEO rights as an applicant (https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .