Outset Medical, Inc. · 3 weeks ago
Sr. Manager, Regulatory Affairs
San Jose, CA
Full-time
Onsite
Senior Level, Lead/Staff
$163K/yr - $221K/yr
8+ years expOutset Medical, Inc. is seeking a highly skilled and experienced professional to join their Regulatory Affairs team as Sr. Manager, Regulatory Affairs. This role involves providing strategic leadership and oversight in all regulatory aspects related to the company's medical device portfolio and collaborating with cross-functional teams to ensure compliance with applicable regulations and standards.
Health CareHealth DiagnosticsMedicalMedical Device
Responsibilities
Develop and execute regulatory strategies for the successful development, registration, and commercialization of medical devices in the US
Provide regulatory guidance and expertise to cross-functional teams, including R&D, Quality Assurance, Clinical Affairs, and Marketing, throughout the product lifecycle
Assess and interpret regulatory requirements and provide recommendations on product development plans, labeling, human factor study, and clinical trial designs to ensure compliance
Manage and review regulatory submissions, including 510(k) premarket notifications, 510(k), De-Novo applications, Pre-submissions, and IDEs
Manage and maintain regulatory documentation, including regulatory files, correspondence with regulatory authorities, and product registrations
Stay current with evolving regulatory requirements, industry trends, and best practices, and proactively communicate updates and potential impacts to stakeholders
Coordinate and liaise with regulatory authorities, such as the FDA, notified body, and other regulatory agencies, to facilitate product approvals, clearances, and registrations
Ensure labeling and advertising materials comply with regulatory requirements and are accurately represented
Establish and maintain relationships with key stakeholders, industry organizations, and trade associations to stay informed about regulatory changes and best practices
Train and educate staff on regulatory requirements, procedures, and best practices
Qualification
Required
Bachelor's degree in a scientific or engineering discipline
Minimum of 8 years of regulatory affairs experience in the medical device industry
In-depth knowledge of medical device regulations and standards, such as FDA regulations (21 CFR Part 820) and ISO 13485
Proven track record of successful regulatory submissions and clearances for medical devices, including 510(k) submissions
Experience interacting with regulatory agencies, such as the FDA and notified bodies
Excellent project management skills, with the ability to prioritize and manage multiple projects simultaneously
Working knowledge for developing a regulatory strategy for SaMD and artificial intelligence (AI) enabled software medical devices in the US
Strong leadership and communication skills, with the ability to collaborate effectively with cross-functional teams and influence key stakeholders
Detail-oriented with exceptional analytical and problem-solving abilities
Regulatory affairs certifications (RAC)
Preferred
Advanced degree (master's or Ph.D.) is preferred
Company
Outset Medical, Inc.
Outset Medical is changing dialysis – one of the largest, most expensive, and stagnant areas of healthcare.
501-1000 employees
H1B Sponsorship
Outset Medical, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (3)
2023 (11)
2022 (10)
2021 (8)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
$1.43BKey Investors
PFM Health SciencesPerceptive AdvisorsSLR Capital Partners
2025-01-06Post Ipo Equity· $168.8M
2025-01-06Post Ipo Debt· $125M
2022-11-04Post Ipo Debt· $300M
Leadership Team
Leslie Trigg
CEO
Michael Aragon
Chief Medical Officer
Recent News
2026-01-06
Company data provided by crunchbase