Associate General Counsel, Regulatory and Compliance

ABOUT INSPIRE MEDICAL SYSTEMS Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients’ lives through sleep innovation.

We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve. WHY JOIN OUR FAST-GROWING TEAM At Inspire, we value people – your diverse experiences, backgrounds, and thoughts.

We elevate voices and encourage learning opportunities to build a professional network that grows into community.

Benefits

, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement. If you’re passionate about making a difference in people’s lives and want to work with innovative technology, come be a part of our great team! ESSENTIAL JOB FUNCTIONS We are seeking an experienced attorney to join the Inspire law department.

We are building a trusting and collaborative culture where we value excellence, professionalism, growth, and development. We engage proactively with our business partners to deliver business-relevant legal advice and solutions. Reporting to the Company’s General Counsel, the Senior Corporate Counsel, Regulatory and Compliance will be a key member of the legal team responsible for a broad range of legal, regulatory and compliance issues affecting the medical device industry, including FDA advertising and promotion, data privacy and protection matters, False Claims Act, Anti-Kickback Statute, OIG Pharmaceutical Compliance Guidance, the Sunshine Act, and related state regulations.

OPPORTUNITIES YOU WILL HAVE IN THIS ROLE Provide legal advice and counsel to sales and marketing teams related to compliance with applicable healthcare laws and regulations, including the False Claims Act, Anti-Kickback Statute, and the Sunshine Act. Assist with the management of the company’s global healthcare compliance and data privacy program, including without limitation, reviewing, drafting and/or revising compliance policies and related standard operating procedures. Educate and advise business partners on healthcare compliance and global privacy matters.

Assist with privileged compliance audits and investigations. Manage outside counsel with respect to compliance, regulatory and data privacy matters. Provide backup legal support for general corporate legal issues as required.

RESPONSIBILITIES

Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed.

Requirements

and competency confirmations as required for this position within the required timeline.

JD degree with strong academic credentials from an accredited law school. REQUIRED EXPERIENCE: 8+ years of legal experience; medical technology industry and corporate legal department is desired. Experience managing domestic and international outside counsel.

Excellent organizational, project management, analytical, and problem-solving skills with attention to detail. Extremely strong written and oral communication skills with a persistent eye toward problem-solving. Adept at operating in a fast-paced, dynamic work environment, and managing competing priorities under demanding deadlines.

Proven ability to work cross functionally and with upper management to achieve regulatory and compliance objectives with support from internal business partners. Demonstrated ability to quickly learn and excel in new or emerging areas.