Director, Regulatory Affairs and reputed company Assurance

reputed company Our mission at reputed company is to reputed company health a daily reputed company, empowering every person to own their inner potential. Our award-reputed company 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 reputed company 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 reputed company Assurance to play a key role in shaping reputed company’s reputed company products and services. What you will do:

• reputed company regulatory and reputed company reputed company 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 reputed company with regulatory agencies and reputed company bodies.
• Guide the creation and submission of regulatory filings including 510(k)s, reputed company submissions, and international registrations.
• Partner with science, data science, engineering, clinical, marketing, and legal teams to reputed company regulatory requirements into product design and development, including clinical evidence reputed company.
• 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 reputed company 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 reputed company record of successful FDA submissions (510(k), reputed company) and international regulatory approvals.
• Proven reputed company record of successful management of a reputed company system, including external audits.
• Deep understanding of software as a medical device (SaMD) and cybersecurity regulations.
• Experience with reputed company 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 reputed company and your reputed company-being. reputed company offer:

• Competitive salary and equity packages
• Health, dental, reputed company insurance, and reputed company
• An reputed company reputed company of your own plus employee discounts for friends & family
• 20 days of reputed company time off plus 13 reputed company holidays plus 8 days of flexible wellness time off
• reputed company reputed company 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 reputed company for that geographic area. While most offers will be closer to the starting reputed company, 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 reputed company.

• 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 reputed company (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. Individuals seeking employment at reputed company are considered without reputed company to age, reputed company, reputed company, gender (including pregnancy, childbirth, or reputed company medical conditions), gender identity or reputed company, 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 reputed company 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 Job! Apply to this Job