Region 1: $143,650 - $169,000; region 2: $130,050 ...
Remote
Fda regulatory framework expertise
Software as medical device (samd) experience
Eu mdr international compliance knowledge
Oura is seeking a Senior Product and Regulatory Counsel to provide legal guidance at the intersection of consumer wellness technology and regulated health products. The ideal candidate will have extensive experience in U.S. medical device regulations, familiarity with wearable technologies, and a collaborative mindset to work across various teams. This is a remote position offering competitive benefits and a focus on employee well-being
Job Summary
The role serves as a lead strategic advisor at the intersection of consumer wellness technology and regulated digital health products.
Candidates will navigate complex global frameworks including FDA and EU MDR while partnering with Product, Engineering, and Clinical teams.
The company offers competitive salary and equity packages along with an Oura Ring for every employee.
Matching Summary
Match Score: 85
Oura is seeking a Senior Product and Regulatory Counsel to provide legal guidance at the intersection of consumer wellness technology and regulated health products. The ideal candidate will have extensive experience in U.S. medical device regulations, familiarity with wearable technologies, and a collaborative mindset to work across various teams. This is a remote position offering competitive benefits and a focus on employee well-being.
Salary
Region 1: $143,650 - $169,000; Region 2: $130,050 - $153,000; Region 3: $117,300 - $138,000
Skills & Requirements
Must-have
FDA regulatory framework expertise
Software as Medical Device (SaMD) experience
EU MDR international compliance knowledge
Cross-functional product team collaboration
Clinical validation strategy guidance
Nice-to-have
Wearable technology industry background
AI and machine learning regulatory familiarity
Prior FDA in-house experience preferred
Agile development environment adaptability
Key Requirements
Juris Doctor (J.D.) degree from accredited U.S. law school
Active license to practice law in the United States
8+ years of relevant legal experience
Deep understanding of U.S. medical device regulations
Familiarity with international medical device regulatory frameworks