Remote Senior Director, Regulatory Affairs and Quality Assurance

Description:

• Oura is seeking a Senior Director of Regulatory Affairs and Quality Assurance to shape the future of its products and services.
• The role involves leading regulatory and quality strategy for product development, approval, and lifecycle management for all regulated features.
• The candidate will ensure compliance with FDA, CE (MDR), and other relevant global regulatory frameworks.
• Responsibilities include reviewing marketing and promotional materials for regulated and general wellness features.
• The individual will serve as the primary liaison with regulatory agencies and notified bodies.
• The role requires guiding the creation and submission of regulatory filings including 510(k)s, De Novo submissions, and international registrations.
• The candidate will partner with various teams to integrate regulatory requirements into product design and development, including clinical evidence strategy.
• Oversight of post-market surveillance, adverse event reporting, and regulatory audits is also required.
• The individual will build and manage the RA/QA team, including hiring, mentoring, and performance development.
• Monitoring regulatory changes and trends to advise the executive team on potential business impacts is essential.
• The candidate will ensure an effective Quality Management System (QMS).
• This position is remote within the US.

Requirements:

• A Bachelor’s degree in life sciences, engineering, regulatory affairs, or a related field is required; an advanced degree is preferred.
• The candidate must have 8+ years of regulatory affairs experience in medical devices, digital health, or wearable technology, with a preference for experience in consumer-facing wearables.
• A proven track record of successful FDA submissions (510(k), De Novo) and international regulatory approvals is necessary.
• The candidate should have a proven track record of successful management of a quality system, including external audits.
• A deep understanding of software as a medical device (SaMD) and cybersecurity regulations is required.
• Experience with privacy and data regulations (e.g., HIPAA, GDPR) is essential.
• Excellent leadership, communication, and stakeholder management skills are necessary.
• The ability to thrive in a fast-paced, dynamic startup environment is required.

Benefits:

• Oura offers a competitive salary and equity packages.
• Health, dental, vision insurance, and mental health resources are provided.
• Employees receive an Oura Ring of their own plus discounts for friends and family.
• The position includes 20 days of paid time off, 13 paid holidays, and 8 days of flexible wellness time off.
• Paid sick leave and parental leave are also included in the benefits package.