Ethics & Compliance Director

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

Outset Medical is seeking a Ethics & Compliance Director to build and manage our compliance program. Reporting to the General Counsel, the successful candidate will drive the continued development and implementation of policies and procedures that facilitate Outset Medical’s compliance with applicable laws; audit Company processes to assess their compliance with policies and procedures; and develop and implement an effective training and communication program.

Essential Job Functions and Responsibilities

• Oversees & directs the day-to-day operation of the corporate ethics and compliance program:
• Drafting and implementing corporate policies and procedures related to healthcare and general compliance.
• Developing and managing effective training and communication in support of Outset’s ethics and compliance program.
• Conducting audits of company processes to assess compliance gaps and areas for improvement, including Sunshine Act reporting.
• Detecting and preventing misconduct through investigations and reviews.
• Conducts risk assessment activities to facilitate the identification of areas of potential vulnerability and risk and partners with the business leads to develop and implement corrective action plans to mitigate risk and enhance process compliance.
• Participates as a stakeholder in vendor diligence.
• Promotes and supports management of the Whistleblower Hotline and responds to alleged violations of rules, regulations, policies, procedures, and standards of conduct by evaluating, initiating, or recommending the initiation of investigative procedures.
• Collaborates with other functional departments and direct compliance reports to appropriate channels for investigation and resolution.
• Provides guidance and support to business partners relating to the interpretation of corporate policy and compliance matters.
• Monitors laws and regulations to determine impacts on the Company’s ongoing compliance.
• Provides reports and metrics to senior leadership of the Company or to the Board of Directors regarding Outset’s ethics and compliance program.

Required Qualifications

• Bachelor’s degree (minimal requirement)
• Prior experience building and maturing compliance programs
• Ability to work effectively in a fast paced and dynamic environment
• Sense of humor and can-do-it-attitude
• Excellent written, verbal, and team building skills
• Exceptional problem solving and analytical skills
• Travel estimated up to 10% as required

Desired Qualifications

• At least 7+ years’ experience in healthcare compliance
• Strong working knowledge of the healthcare business and regulatory environment at the US federal and state level, including the Anti-Kickback Statute, the False Claims Act, the Sunshine Act / state transparency reporting requirements as well as knowledge of the FCPA, conflicts of interest, gifts and entertainment and similar issues
• Previous experience working in the medical device or life sciences industry
• Graduate or Law Degree preferred
• CHC, CPCO, CCS certifications desirable
• Working knowledge of privacy laws, including HIPAA and CCPA

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 fede