Sr. Manager, Regulatory Affairs

Company Overview

Join us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis. Our focus is to create one high performing team, obsessed with progress, in an atmosphere that is brimming with transformative opportunities. The heart of our mission is pioneering a groundbreaking technology that redefines the landscape of dialysis, streamlining complexity and cost, because patients deserve “better” now, not some day.  

At Outset we’re revolutionizing an industry and changing lives. We’re impacting what the future of dialysis looks like by creating a first-of-its-kind technology in order to reduce the cost and complexity of dialysis. FDA cleared for use across care settings, from the hospital to the clinic to the home, the Tablo® Hemodialysis System harnesses modern technology for a new holistic approach to dialysis care. We’re giving providers time back to focus on patient care. And we’re giving patients the power to take control of their life and get back to enjoying the things they love.

Position Overview:

We are seeking a highly skilled and experienced professional to join our Regulatory Affairs team as Sr. Manager, Regulatory Affairs. In this role, you will provide strategic leadership and oversight in all regulatory aspects related to our medical device portfolio. You will collaborate closely with cross-functional teams to develop and execute regulatory strategies that align with business goals and ensure compliance with applicable regulations and standards.

Essential Job Functions and 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.

Required Qualifications: 

• 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).

Desired Qualifications:

• Advanced degree (master’s or Ph.D.) is preferred.

Company Culture

At Outset, we believe every person matters. Every Outsetter, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with intelligent speed. Our team expects nothing less than our best display of strengths and skills, and we find joy in working together for a common goal. At Outset, we believe that curiosity, ingenuity and conviction in the power of technology will transform the lives of dialysis patients and providers. 

We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU, our future Outsetter. At Outset, we’ve designed a professional world that our employees are honored and impassioned to belong to, one that offers challenge, the ability to collaborate with great people, and opportunities to build skill and expertise in a fulfilling career. 

An opportunity at Outset Medical won’t just be about finding a job. Our culture revolves around the principles of moving farther, faster, together, so working here feels like a masterclass in peak performance, for individuals and teams. 

Privacy is important to us. Please review our Applicant Privacy Notice. 

Important Notice

We have been made aware of fraudulent activities where individuals are impersonating our company and offering fake job opportunities. Please note, Outset Medical will never request payment or gift cards during the hiring process, nor will we ask you to purchase your own equipment. Anyone reaching out to you with an email address ending in @outsetmedical.cc, is not a legitimate Outset representative. For legitimate opportunities, always apply directly through our official careers page. If you are unsure about the authenticity of a communication, contact us immediately at peopleops@outsetmedical.com.

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT 

Outset Medical is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization.