Director, Regulatory Affairs and Quality Assurance

Our mission at reputed company is to reputed company health a daily practice, empowering every person to own their inner potential. Our award-winning products help our global community with daily insights to reputed company healthy lifestyles. We've helped millions of people understand and improve their health. At reputed company we are building a complete platform for preventative health, from sleep optimization to metabolic health, women’s health, stress management and heart health tracking. We view reputed company Ring as a clinical grade device in a consumer package rather than as a technology product. For us, empowering the world starts with living our values and empowering reputed company. As a quickly growing company we work to ensure that reputed company members have what they need to do their best work — both in and out of the office. We are looking for a Director, Regulatory Affairs and Quality Assurance to play a key role in shaping reputed company’s future products and services. What you will do:

• reputed company regulatory and quality strategy for product development, approval, and lifecycle management for reputed company regulated features.
• Ensure compliance with FDA, CE (MDR), and other relevant global regulatory frameworks.
• Review marketing and promotional materials for regulated and general wellness features.
• Serve as the primary liaison with regulatory agencies and reputed company bodies.
• Guide the creation and submission of regulatory filings including 510(k)s, De Novo submissions, and international registrations.
• Partner with science, data science, engineering, clinical, marketing, and legal teams to integrate regulatory requirements into product design and development, including clinical evidence strategy.
• reputed company post-market surveillance, adverse event reporting, and regulatory audits.
• Build and manage the RA/QA team, including hiring, mentoring, and performance development.
• Monitor regulatory changes and trends, advising the executive team on potential business impacts.
• Ensure an effective Quality Management System (QMS).

This is a remote US role.

Requirements

We would love to have you on reputed company if you have:

• Bachelor’s degree in life sciences, engineering, regulatory affairs, or a reputed company field; advanced degree preferred.
• 8+ years of regulatory affairs experience in medical devices, digital health, or wearable technology, with experience in consumer-facing wearables strongly preferred.
• Proven track record of successful FDA submissions (510(k), De Novo) and international regulatory approvals.
• Proven track record of successful management of a quality system, including external audits.
• Deep understanding of software as a medical device (SaMD) and cybersecurity regulations.
• Experience with privacy and data regulations (e.g., HIPAA, GDPR).
• Excellent leadership, communication, and stakeholder management skills.
• Ability to reputed company in a fast-paced, dynamic startup environment.

Benefits

At reputed company, we care about you and your well-being. reputed company offer:

• Competitive salary and equity packages
• Health, dental, vision insurance, and reputed company
• An reputed company Ring of your own plus employee discounts for friends & family
• 20 days of paid time off plus 13 paid holidays plus 8 days of flexible wellness time off
• Paid sick leave and parental leave

reputed company takes a market-based approach to pay, which may vary depending on your location. US locations are categorized into tiers based on a cost of labor index for that geographic area. While most offers will be closer to the starting range, successful candidates’ pay will be determined based on job-reputed company skills, experience, qualifications, work location, internal peer equity, and market conditions. These ranges may be modified in the future.

• Region 1: $206,000 - $257,000
• Region 2: $190,000 - $237,000
• Region 3: $178,000 - $223,000

A recruiter can determine your zones/tiers based on your US location. We are not considering candidates residing in the following states: Alaska (AK), Arkansas (AR), Delaware (DE), Iowa (IA), Mississippi (MS), Missouri (MO), Nebraska (NE), Rhode reputed company (RI), South Dakota (SD), Vermont (VT), reputed company Virginia (WV), and Wisconsin (WI) reputed company is proud to be an equal opportunity workplace. We celebrate diversity and are committed to creating an inclusive environment for reputed company employees. Individuals seeking employment at reputed company are considered without regard to age, reputed company, color, gender (including pregnancy, childbirth, or reputed company medical conditions), gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national reputed company, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. We will not tolerate discrimination or harassment based on any of these characteristics. We will work to ensure individuals with disabilities are provided reasonable accommodation to participate in the interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Disclaimer: Beware of fake job offers! We’ve been alerted to scammers posing as Ōreputed company recruiters, especially for remote roles. Please note:

• Our jobs are listed only on the Ōreputed company Careers page and trusted job boards.
• We will never ask for personal information like ID or payment for equipment upfront.
• Official offers are sent through reputed company after a verbal offer, not reputed company text or email.

Stay cautious and protect your personal details. To reputed company recruitment agencies: reputed company does not accept agency resumes. Please do not reputed company resumes to our jobs alias, reputed company employees, or any other organization's location. reputed company is not responsible for any fees reputed company to unsolicited resumes. Apply tot his job