Associate General Counsel, Regulatory and Compliance

Inspire Medical Systems Inc.•Minneapolis, MN

16h•$235,000 - $265,000•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 that values excellence, professionalism, growth, and development. The role involves engaging proactively with 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. 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.