[All remote jobs](https://jobicy.com/jobs.md)[![ŌURA logo](https://jobicy.com/data/server-nyc0409/galaxy/mercury/2026/07/011c99434cd6-221.webp)](https://jobicy.com/company/oura.md)[ŌURA](https://jobicy.com/company/oura.md) # Senior Regulatory Affairs Specialist AI Summary Oura is hiring a Senior Regulatory Affairs Specialist to support regulatory strategy and operations for its Software as a Medical Device portfolio. The role manages regulatory submissions, product registrations, controlled documentation, change-impact assessments, and audit readiness across the product lifecycle. It requires at least five years of medical device, digital health, or regulated healthcare regulatory experience, including familiarity with FDA requirements, EU MDR, ISO 13485, IEC 62304, and ISO 14971. The specialist will work closely with quality, engineering, product, clinical, and legal stakeholders in a fast-moving medtech environment. This is a US-remote role, with several US states excluded from eligibility.[Apply for this job](#job-application)[View company](https://jobicy.com/company/oura.md)ShareRemote from[USA](https://jobicy.com/job-region/usa.md)SalaryUSD 127,500–178k / yrDepartment[Legal & Compliance](https://jobicy.com/categories/legal.md)EmploymentFull TimeExperienceSeniorPublished3 Nov 2026Apply before3 Dec 2026Listing views31Application actions1Application toolkit ## Make your next move. Prepare your resume, explore your fit, and draft a cover letter for this opportunity. Opportunity details ## About this role. Our mission at ŌURA is to empower every person to own their inner potential. Our award-winning products help our global community gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. We’ve helped millions of people understand and improve their health by providing daily insights and practical steps to inspire healthy lifestyles. Empowering the world starts with living [our values](https://ouraring.com/about-us) and empowering our team. As a quickly growing company focused on helping people live healthier and happier lives, we ensure that our team members have what they need to do their best work — both in and out of the office. We are seeking a Senior Regulatory Affairs Specialist to support regulatory strategy/operations for our Software as a Medical Device (SaMD) portfolio. This role will help drive compliant and efficient execution of regulatory activities across the product lifecycle, including submission support, document management, change assessments, registrations, regulatory intelligence, and inspection/audit readiness. The ideal candidate brings hands-on experience in medical device or digital health regulatory affairs, strong operational discipline, and the ability to work cross-functionally with quality, engineering, product, clinical, and legal teams in a fast-paced environment. What You Will Do * Lead regulatory and quality strategy for product development, approval, and lifecycle management for wellness and regulated features. * Support regulatory operations lead for SaMD products across development, submission, launch, and post-market phases * Coordinate preparation, compilation, publishing, and archival of regulatory submissions and related correspondence * Maintain regulatory documentation, including: submission trackers * product registrations/listings * regulatory commitments * approvals and clearance records * change assessment logs * Support design change assessments and help determine regulatory filing impact for software updates, labeling changes, and product modifications * Track and communicate submission milestones, approvals, renewals, and post-market reporting requirements * Support UDI, registration, listing, and market access maintenance activities where applicable * Contribute to inspection and audit readiness by organizing regulatory evidence and ensuring documentation is current and inspection-ready * Monitor evolving regulations, guidance, and standards relevant to SaMD, and help translate changes into operational actions * Collaborate with cross-functional stakeholders to improve regulatory processes, templates, and tools for scale and efficiency Requirements: * Bachelor’s degree in a scientific, engineering, healthcare, or related discipline * 5+ years of experience in regulatory affairs or regulatory operations within medical devices, digital health, or other regulated healthcare products * Experience supporting software-based medical products or SaMD * Familiarity with key regulatory frameworks and standards, such as: * FDA medical device requirements * EU MDR * ISO 13485 * IEC 62304 * ISO 14971 * Experience compiling and maintaining regulatory documentation in a controlled environment * Strong project coordination, organization, and document management skills * Excellent written and verbal communication skills * Ability to manage multiple priorities and deadlines with strong attention to detail Preferred Qualifications: * Experience supporting 510(k), De Novo, technical documentation, or international registrations * Familiarity with eQMS, document control, and submission management tools * Experience with software change assessments, traceability, and lifecycle documentation * Understanding of cybersecurity, labeling, and post-market requirements for SaMD * RAC certification or other relevant regulatory training is a plus * Experience working in a fast-paced startup or high-growth medtech environment is preferred Benefits At Oura, we care about you and your well-being. Everyone here at Oura has a ring of their own and we are continually looking to improve employee health. What we offer: * Competitive salary and equity packages * Health, dental, vision insurance, and mental health resources * An Oura 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 Oura 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-related skills, experience, qualifications, work location, internal peer equity, and market conditions. These ranges may be modified in the future. * Region 1: $151,300 – $178,000 * Region 2: $138,550 – 163,000 * Region 3: $127,500 – $150,000 A recruiter can determine your zones/tiers based on your US location. We are not considering candidates residing in the following states: Alaska (AK), Delaware (DE), Iowa (IA), Mississippi (MS), Nebraska (NE), South Dakota (SD), West Virginia (WV), and Wisconsin (WI). ŌURA is proud to be an equal opportunity workplace. We celebrate diversity and are committed to creating an inclusive environment for all employees. Individuals seeking employment at ŌURA are considered without regard to age, ancestry, color, gender (including pregnancy, childbirth, or related medical conditions), gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, 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 perform 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 ŌURA recruiters, especially for remote roles. Please note: * Our jobs are listed only on the ŌURA 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 Docusign after a verbal offer, not via text or email. Stay cautious and protect your personal details. To all recruitment agencies: ŌURA does not accept agency resumes. Please do not forward resumes to our jobs alias, ŌURA employees, or any other organization’s location. ŌURA is not responsible for any fees related to unsolicited resumes. Show more [Apply now >](https://jobicy.com/jobs/158772-senior-regulatory-affairs-specialist.md) * ![Upload CV](data:image/svg+xml;base64,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) ### Upload your resume now To unlock remote work opportunities and be discovered by global employers. This job listing has been manually reviewed by the Jobicy Trust & Safety Team for compliance with our posting guidelines, including verification of the company's legitimacy, accuracy of job details, clarity of remote work policy, and absence of misleading or fraudulent content. ## Role DNA A quick view of the complexity, pace, ownership and collaboration implied by the job description. ### Job Complexity 4/5EasyHard ### Pace & Pressure 4/5RelaxedFast-paced ### Autonomy Level 4/5GuidedFull ownership ### Communication Load 5/5IndependentCollaborative AI insightThe position requires specialized expertise in SaMD regulations and the ability to assess regulatory impacts of software and labeling changes. Success depends on independently maintaining rigorous documentation while coordinating complex work across multiple technical and business functions. ## Salary analysis Estimated compensation compared with the broader US market for similar roles. Estimated job median (per year)Market rate$152,750US market range (per year)$135k–$175k0$192.50k AI insightThe yearly pay period is inferred from the job context; it was not explicitly stated by the employer. The employer publishes location-tiered US salary ranges of $127,500 to $178,000. The yearly period is inferred from the senior US regulatory-affairs role and the stated pay levels, rather than explicitly stated. A reasonable estimated US market range for a Senior Regulatory Affairs Specialist with SaMD experience is $135,000–$175,000 per year. ## Core skills Skills and capabilities most closely associated with this opportunity. [Regulatory Affairs](https://jobicy.com/jobs?search_keywords=Regulatory%20Affairs.md)[Software as a Medical Device](https://jobicy.com/jobs?search_keywords=Software%20as%20a%20Medical%20Device.md)[FDA Medical Device Regulations](https://jobicy.com/jobs?search_keywords=FDA%20Medical%20Device%20Regulations.md)[EU MDR](https://jobicy.com/jobs?search_keywords=EU%20MDR.md)[ISO 13485](https://jobicy.com/jobs?search_keywords=ISO%2013485.md)[IEC 62304](https://jobicy.com/jobs?search_keywords=IEC%2062304.md)[ISO 14971](https://jobicy.com/jobs?search_keywords=ISO%2014971.md)[Regulatory Submissions](https://jobicy.com/jobs?search_keywords=Regulatory%20Submissions.md)[510(k) Submissions](https://jobicy.com/jobs?search_keywords=510k%20Submissions.md)[Regulatory Document Control](https://jobicy.com/jobs?search_keywords=Regulatory%20Document%20Control.md)[Design Change Assessment](https://jobicy.com/jobs?search_keywords=Design%20Change%20Assessment.md)[UDI and Product Registration](https://jobicy.com/jobs?search_keywords=UDI%20and%20Product%20Registration.md)[eQMS](https://jobicy.com/jobs?search_keywords=eQMS.md)[Audit Readiness](https://jobicy.com/jobs?search_keywords=Audit%20Readiness.md)[Post-Market Surveillance](https://jobicy.com/jobs?search_keywords=Post-Market%20Surveillance.md) Sample interview questionsHow would you assess whether a SaMD software update requires a new regulatory filing?I would first define the intended change, affected claims, risk controls, software requirements, verification evidence, and patient or user impact. I would then apply the applicable FDA, EU MDR, and internal change-control criteria, document the rationale, and align the conclusion with quality, engineering, and regulatory leadership before implementation. Describe your approach to compiling a regulatory submission in a controlled environment. I create a submission plan with required sections, owners, timelines, review checkpoints, and version-control expectations. I verify that all source records are approved and traceable, conduct a completeness and consistency review, manage publishing activities, and archive final correspondence and submission evidence in the controlled system. How do you stay current with changing SaMD regulations and translate them into action? I monitor regulator communications, standards updates, industry associations, and notified-body or agency guidance. I assess relevance to the product portfolio, summarize operational impact, update procedures or templates where needed, and communicate prioritized actions to affected stakeholders. What documentation would you prepare to support inspection or audit readiness? I would ensure that submission histories, approvals, registrations, change assessments, traceability records, regulatory commitments, and post-market reports are current, accessible, and consistently indexed. I would also conduct readiness checks to identify gaps and coordinate timely remediation with document owners. How do you manage competing regulatory deadlines across multiple products? I use a centralized tracker that captures submission milestones, dependencies, renewal dates, risks, and accountable owners. I regularly review priorities with cross-functional teams, escalate blockers early, and adjust plans based on product and regulatory risk while preserving documentation quality. Next step ## Apply now. 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