Apple

International Regulatory Affairs Lead (Medical Devices)

Apple$130K — $180K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • B.S. degree in life sciences, legal, or business; M.S./PhD preferred.
  • 10+ years in medical device regulatory or quality roles with international focus.
  • 5+ years in leadership of global regulatory affairs programs.
  • Proven track record with regulatory approvals and launch strategies globally.
  • Deep knowledge of global regulations affecting Class I, II, III devices.

Responsibilities

  • Lead the Health Regulatory Affairs team and represent in executive meetings.
  • Identify regulatory trends and create plans for sustained growth in international markets.
  • Cultivate relationships with regulators and trade groups globally.
  • Collaborate with cross-functional teams to align on regulatory strategies.
  • Develop frameworks for technical writing and geo-specific submissions.
  • Conduct gap analyses to inform regulatory strategy for international expansions.

Benefits

  • Collaborative work environment across various functional teams.
  • Opportunity to influence global health technology regulations.
  • Chance to work with a highly regarded brand in the health tech space.
  • Potential for professional growth in a leading technology company.
Full Job Description
You will be the primary leadership team member on the Health Regulatory Affairs team representing the team on a diverse array of initiatives and new product development programs, with the goal of marketing new technologies in all of Apple's international geographies. You will develop a variety of solutions to regulatory challenges and will exercise independent judgment in settling and communicating appropriate regulatory/quality strategy, actions and requirements, while overseeing a team of global regulatory experts across all geographies. This role will involve leading assessments of regulatory impact for new and modified wellness, Class I, II and III products, including identification of assumptions/risks/mitigations to develop and execute clear regulatory plans across the globe. In this leadership role, you will also: • Represent the Health Regulatory Affairs team in Executive meetings and reviews for topics representing our international expansion work. • Identify regulatory trends and opportunities that impact the strategic direction of Apple Health, and establish / implement plans that ensure sustained growth of business in region. • Build strong relationships with external stakeholders, including regulators and trade groups, across key global markets • Partner with cross-functional partners including Legal, Government Affairs, Policy, Quality and other external stakeholders • Set frameworks for technical writing, including distilling complex information into geo-specific filings, submissions, slides and other communication formats • Execute complex gap analyses for products/ programs against global regulations, standards and guidance in order to drive RA/QA strategy for international expansion programs B.S. degree or equivalent in a life science, legal or business discipline 10+ years of medical device experience in a regulatory and/ or quality executive role, with at least 5+ years focused in leading and overseeing international programs Proven track record in overseeing a large scope of international regulatory affairs matters including regulatory approvals, submissions, launch strategy Experience leading global team of regulatory professionals, including establishing organizational objectives and proven success delivering as a team Significant experience in crafting strategy interactions with regulatory health authorities in the US and abroad Demonstrable track record of receiving regulatory approvals for complex products - including software medical devices - globally, across US, EU, APAC, LATAM, ASEAN and other regions Deep expertise in developing global product submissions including STED, CDST and other global templates Strong working knowledge of US, EU, APAC, LATAM, ASEAN and other global regulations that affect Class I, II and III devices Strong knowledge of clinical investigations, validations and GCP requirements in the US and abroad Significant expertise in global quality standards, including ISO 13485, ISO 14155, and related technical product-specific standards M.S./ PhD / post-secondary education preferred Demonstrable background in being autonomous and being able to clearly work towards establish goals and initiatives with minimal oversight. Proven competence in determination of appropriate global regulatory requirements for new products or product changes. Partnering with and across a broad swath of other Apple teams to set regulatory / quality strategy and "look around corners" to anticipate business impact Strong organizational and management skills Excellent communication skills, both verbal and written Comfortable with presenting assessments and information to broad, multi-disciplinary teams

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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