Regulatory Post-Market and New Market Access Analyst

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! Job Description: Provide regulatory support for neurostimulation therapy for the treatment of obstructive sleep apnea in adult and pediatric patients. Focus on US and international regulatory submissions and evaluate market access requirements for new geographies in Asia and Latin America, e.g., India, Brazil, and others as required. Conduct regulatory assessments of design and manufacturing changes, e.g. engineering change orders and supplier change requests. Assist with manufacturing and design changes and new product development submissions, as well as conducting gap assessments between Inspire’s US and EU regulatory documentation and the regulatory requirements in new geographies. Interact directly with regulatory agencies at the reviewer level. Review labeling and promotional material for regulatory compliance. Generate and approve design history file documents, device master record documents, engineering change order records, and other quality system documents and records as assigned. Job Requirements: Bachelor’s degree in engineering, pharmacy, or relevant scientific field. Five (5) years of progressive experience in Regulatory Affairs or a related discipline in the medical device industry. Two (2) years of experience specifically in Regulatory Affairs, which may have been gained as part of or in addition to the required progressive experience. Experience must include: US Class III devices. Authoring a variety of regulatory submissions for US and EU related to implantable devices. Basic submission processing experience with submission portal use and fee processing systems Microsoft Word, Excel, PowerPoint and Adobe Acrobat. Must have current authorization to be employed in the U.S. without employer sponsorship. #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 $110,178 — $130,000 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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