Apple

Regulatory Affairs Associate (Principal) - Medical Devices

Apple$120K — $150K *
Healthcare
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • B.S. in Engineering (ME/EE/BME/CS) or equivalent required
  • 10+ years of regulatory experience in the medical device sector
  • 5+ years in a leadership role (principal, manager, or lead)
  • Extensive experience interacting with the US FDA
  • Proven expertise in preparing regulatory filings (e.g., pre-submissions, 510(k)s, De Novos, IDEs)
  • Solid understanding of US regulations for Class I, II, and III devices
  • Experience with Software as a Medical Device (SaMD) and algorithm-based products

Responsibilities

  • Represent the RA/QA team on regulatory initiative teams
  • Develop solutions for regulatory challenges
  • Assess regulatory impact of new and modified products
  • Identify risks, assumptions, and mitigations for regulatory plans
  • Execute regulatory plans in the US and globally
  • Communicate regulatory action and requirements effectively
  • Collaborate with engineering to establish regulatory strategy

Benefits

  • Hybrid work environment with onsite requirements
  • Opportunity to work on innovative technologies
  • Engagement with a diverse range of regulatory initiatives
  • Work within a collaborative project team
  • Professional development in global regulatory strategies
Full Job Description
Description

You will represent the RA/QA team on a diverse array of regulatory initiative teams and new product development, with the goal of obtaining approvals for new technologies. You will demonstrate the ability to develop a variety of solutions to regulatory challenges and will exercise independent judgment in settling and communicating appropriate regulatory action and requirements. This role will involve assessment of regulatory impact for new and modified Class I, II and III products, including identification of assumptions/risks/mitigations to develop and execute clear regulatory plans in the US and globally.

Minimum Qualifications

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

10+ years of medical device experience in a regulatory role, with at least 5+ years as a principal, manager or lead.

Significant experience in leading interactions with the US Food & Drug Administration.

Significant experience preparing regulatory filings, including pre-submissions, 510(k)s, De Novos, and IDEs.

Strong working knowledge of US regulations that affect Class I, II and III devices.

Experience with Software as a Medical Device (SaMD) and algorithm- or sensor-based products, including how regulatory strategy interacts with clinical study design and algorithm performance.

Ability to be onsite; this role is a hybrid, in-person position.

Preferred Qualifications

Global regulatory strategy experience (e.g., EU MDR) is a strong plus.

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

Working as part of a focused project team.

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

Partnering with and across engineering teams to set regulatory strategy.

Strong organizational and management skills.

Excellent communication skills, both verbal and written.

About Apple

Apple is a corporation that designs, manufactures, and markets mobile communication and media devices, personal computers, portable digital music players, and sells a variety of related software, services, peripherals, networking solutions, and third-party digital content and applications. Apple provides many products and services, including iPhone; iPad; iPod; Mac; Apple TV; a portfolio of consumer and professional software applications; the iOS and OS X operating systems; iCloud; and accessories, service, and support offerings. It sells its products worldwide through its retail stores, online stores, direct sales force and third-party cellular network carriers, wholesalers, retailers, and value-added resellers to the consumer and also sells third-party iPhone, iPad, Mac and iPod compatible products, including application software and accessories through its online and retail stores. Introduced in 1984, the Macintosh was the first widely sold personal computer with a graphical user interface (GUI). That feature and others such as an improved floppy drive design and a low-cost hard drive that made data retrieval faster helped Apple cultivate a reputation for innovation. Apple was named as the most admired company in the United States in 2008 and in the world from 2008 to 2012 by the Fortune magazine. The company was founded by Steven Paul Jobs, Steve Wozniak, and Ronald Gerald Wayne on April 1, 1976, and is headquartered in Cupertino, California.

Apple Careers

Join Apple, a place where extraordinary people gather to do their best work. Our ever-expanding global team is at the forefront of innovation and leadership in the tech industry. At Apple, we're not just building products—we're crafting the kind of wonder that revolutionizes entire industries. It's the diversity of our people and their ideas that inspires the innovation that runs through everything we do, from amazing technology to industry-leading environmental efforts. Work You’ll Do Embark on a journey with Apple’s market-leading team to help some of the world’s most influential companies navigate their path to digital mastery with cutting-edge technology and services. Transform industries and touch lives with your unique ideas at Apple. Here, you’ll lead through a unique position at the intersection of technology, creativity, and robust industry expertise. Collaborate with a global team of professionals who are at the top of their game in technology and design. Apple isn’t just a company, it’s a community of innovators and passionate thinkers. Introducing the Apple Innovation and Leadership Initiative We are building a market-leading team to drive our efforts in delivering groundbreaking solutions and services. At Apple, job opportunities are abundant, offering you the chance to explore diverse roles from engineering to marketing, all designed to empower your career growth. Do Innovative Work Join the largest group of creative and technical experts in the world—professionals dedicated to redefining what’s possible through technology and innovation. Deliver targeted solutions through a depth and breadth of expertise that’s unmatched, driving forward our commitment to excellence and leadership in every project we undertake. Be Part of a Great Team Engage in a wide range of projects utilizing Apple’s technology and resources. Harness the unparalleled capabilities, global scale, and joint solution development that only Apple can offer. Future-Proof Your Career Advance your career with limitless opportunities at Apple. Go as far as your ambition takes you with unmatched training, development, and certification support. Explore Discover how Apple is leading the way in tech innovation: [With iOS] Businesses can streamline operations and enhance customer interactions... READ MORE Smart home technology integration that sets the standard for convenience and security... READ MORE The Apple Experience Our combined service capabilities, global scale, and joint solution development help clients overcome challenges and lead transformation in their industries. Clients worldwide look to Apple for new strategies and solutions that drive growth and innovation in the digital era. Stay Connected Join Our Team Search open positions that match your skills and interests. We look for passionate, curious, creative, and solution-driven team players. Whether you’re seeking a professional role, an internship, or a leadership position, Apple offers a variety of employment opportunities. SEARCH APPLE JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. See what exciting and rewarding opportunities await at Apple, a company committed to diversity, innovation, and leadership. Explore job opportunities, employment benefits, and the culture of growth and innovation at Apple. Prepare your resume, hone your interview skills, and ready yourself for a career at one of the most prestigious companies in the world. Join us in pushing the boundaries of what is possible.
Learn more about Apple
Size
154,000 employees
Market Cap
$2,074.3 billion
Industry
Net Income
$63.9 billion
Founded
1976
5 Year Trend
+11.5%
Revenue
$294.1 billion
NASDAQ

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