Regulatory Affairs Associate (Principal) - Medical Devices

Apple Inc.; Cupertino (CA); Hybrid; USD 178,000 - 297,000; Full time

Benefits offered by this job

Stock programs

Educational reimbursement

Relocation assistance

Employee discounts

Job summary

Apple Inc. is seeking a Principal Regulatory Affairs Associate in Cupertino, CA, to lead regulatory strategy for medical devices and SaMD products. This hybrid, in-person role will drive submissions and regulatory plans for US and global markets.

The successful candidate will have extensive FDA experience and a strong engineering background, with oversight responsibilities in a fast-paced Health group. You will work across cross-functional teams to ensure regulatory compliance, manage complex

Qualifications

• B.S. ME/EE/BME/CS or equivalent in engineering.
• 10+ years medical device regulatory experience, with 5+ years in principal/lead roles.
• Significant experience interacting with the US FDA.

Responsibilities

• Represent the RA/QA team on regulatory initiative teams and new product development.
• Develop regulatory plans for US and global markets with clear strategies.
• Assess regulatory impact for Class I–III products and identify risks and mitigations.
• Collaborate with engineering and clinical teams to shape regulatory strategy.

Skills

Regulatory leadership

FDA interactions

Regulatory strategy

SaMD knowledge

Education

B.S. in engineering

10+ years device regulatory experience

5+ years principal/lead

Job description

Regulatory Affairs Associate (Principal) - Medical Devices

Cupertino, California, United States Software and Services

Imagine what you could do here. At Apple, excellent ideas have a way of becoming great products, services, and customer experiences. Bring passion and dedication to your job, and there’s no telling what you could accomplish. The people at Apple don’t just build products — we craft the kind of wonder that’s revolutionized entire industries.The Health group is looking for a Principal Regulatory Affairs Associate to help drive strategy and submissions for health products. 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 team who works closely together to build relationships across multiple functional teams. We care deeply about getting amazing new products into our customers hands. We come to Apple to think creatively about how to launch products within a rigorous regulatory structure for medical devices.

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.

At Apple, base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The base pay range for this role is between $178,400 and $297,200, and your base pay will depend on your skills, qualifications, experience, and location.

Apple employees also have the opportunity to become an Apple shareholder through participation in Apple’s discretionary employee stock programs. Apple employees are eligible for discretionary restricted stock unit awards, and can purchase Apple stock at a discount if voluntarily participating in Apple’s Employee Stock Purchase Plan. You’ll also receive benefits including: Comprehensive medical and dental coverage, retirement benefits, a range of discounted products and free services, and for formal education related to advancing your career at Apple, reimbursement for certain educational expenses — including tuition. Additionally, this role might be eligible for discretionary bonuses or commission payments as well as relocation. Learn more about Apple Benefits

Note: Apple benefit, compensation and employee stock programs are subject to eligibility requirements and other terms of the applicable plan or program.

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

At Apple, we believe accessibility is a fundamental human right. You’ll find that idea reflected in everything here — in our culture, our benefits and our digital tools. By welcoming as many perspectives as possible, we help you build a career where you feel like you belong.

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Apple accepts applications to this posting on an ongoing basis.