Ethics & Compliance Director

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 federal, state, or local laws. This policy applies to all employment practices within our organization.

The Annual Salary Range for this position is: $220,000 - $ *

We feel passionately about pay equality. Discretionary adjustments to the position's starting compensation may be made in consideration of other relevant factors pertaining to eligible applicants, including, but not limited to, their specific skills, level, geographical location, and comparison to other employees already in the same or similar roles.

• This range represents our good-faith and reasonable estimate regarding what we reasonably expect to pay for this position at the time of posting.

Outset also offers the following benefits:

• Medical

• Dental

• Vision

• EAP/Mental Health

• Life Insurance/AD&D

• Short/Long Term Disability

• FSA (Dependent & Healthcare)

• HSA w/ Employer contribution

• Commuter Benefits

• 401K w/ company match

• ESPP

• Fertility benefits

• Wellness initiatives

• Legal Assistance

• Pet insurance

• Financial Advisement & Wellbeing

• Tuition Reimbursement

• Student Loan Payback

• Employee discounts

• Professional Development/Learning

• Collaboration Days (lunch onsite)

• Happy Hours/Karaoke

• PTO/Sick time

• Holidays + Volunteer Day