Associate General Counsel, Regulatory and Compliance

Inspire Medical Systems • Minneapolis, MN

9h • Onsite

About The Position

Inspire Medical Systems is seeking an experienced attorney to join their law department. The company is building a trusting and collaborative culture where excellence, professionalism, growth, and development are valued. The legal team engages proactively with business partners to deliver business-relevant legal advice and solutions. 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. This includes 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.

Requirements

• JD degree with strong academic credentials from an accredited law school.
• 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.
• Admission to a State Bar in good standing.
• Judgement, discretion, strong communication skills, creativity, courage, and the ability to embrace working in a challenging and dynamic atmosphere.
• Ability to operate with a significant degree of independence and transparency, and be capable of articulating a vision and strategy for the legal function, as well as ensuring high quality execution.
• An entrepreneurial, creative, hands-on adviser who has the ability to drive solutions to problems quickly and effectively.
• An outstanding team player who is not afraid to roll up their sleeves to get a task done and is inherently proactive, driven, collaborative, dedicated, and possesses the ability to develop first-class relationships, both internally and externally.
• A smart, innovative, strategic thinker, yet pragmatic and operationally savvy, with a strong commitment to building shareholder and patient value.
• A natural communicator who is able to present ideas discerningly, articulately and openly with the ability to effectively influence and marshal buy-in from people at all levels.

Nice To Haves

• medical technology industry and corporate legal department is desired

Responsibilities

• 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.
• 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.
• Complete training requirements and competency confirmations as required for this position within the required timeline.

Benefits

• Multiple health insurance plan options.
• Employer contributions to Health Savings Account.
• Dental, Vision, Life and Disability benefits.
• 401k plan + employer match.
• Identity Protection.
• Flexible time off.
• Tuition Reimbursement.
• Employee Assistance program.
• Employees at all levels can participate through equity awards and the Employee Stock Purchase Program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree