
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. We embrace a people-first culture by offering excellent 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.
QUALITY SYSTEM 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.
- Complete training requirements and competency confirmations as required for this position within the required timeline.
WHAT YOU CAN BRING TO OUR GREAT TEAM
EDUCATIONAL REQUIREMENTS
- 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.
- 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.
#LI-Onsite
The salary for this position will be offered at a level consistent with the experience and qualifications of the candidate. This information reflects the anticipated salary range for this position at the time of posting. The salary range may be modified in the future and actual compensation may vary from the posting based on various factors such as geographic location, work experience, education and/or skill level.
Salary
$235,000 - $265,000 USD
BENEFITS AND OTHER COMPENSATION
Inspire offers a highly competitive benefits package including (general description of the benefits and other compensation offered):
- 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.
- All employees have the opportunity to participate in the ownership and success of Inspire. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program.
Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status regarding public assistance, membership or activity in a local commission, military or veteran status, genetic information, pregnancy or childbirth, or any other status protected by applicable federal, state, and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training, and social and recreational programs. Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.
Inspire Medical Systems is an equal opportunity employer with recruitment efforts focused on ensuring a diverse workforce. Applicants with a disability that need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at 844-672-4357 or email careers@inspiresleep(dot)com
Inspire Medical Systems participates in E-Verify.
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