Job Description

Job Description

Job Description

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 hybrid work schedules, 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

The International Regulatory Affairs Specialist provides regulatory support for implantable neurostimulation therapy for the treatment of obstructive sleep apnea. This role will focus on submission preparation, manufacturing and design change assessments, and supporting vigilance activities for Asia Pacific geographies. This role will collaborate with in-country partners to meet regulatory objectives.

OPPORTUNITIES YOU WILL HAVE IN THIS ROLE

• Prepare documentation to support submission of new products and product changes.
• Coordinate regulatory assessment of product design and manufacturing changes.
• Work with technical experts in product development, quality, and clinical to address regulatory agency questions.

• Document field reports and complaints for regulatory reporting.
• Interact with international regulatory partners in local offices to support submission contents, as well as foreign regulatory agency reviewers to answer questions.
• Review labeling and promotional material for regulatory compliance.

WHAT YOU CAN BRING TO OUR GREAT TEAM

Required:

• Bachelor’s degree
• 1 year minimum medical device industry experience in regulatory or quality function.
• Strong writing and communication skills.

Preferred:

• Familiarity with EU, and/or other international medical regulations, device testing, and quality standards.
• Support for international regulatory agency submissions.
• International work experience or study abroad educational background.
• Complaint handling and/or post-market change assessment experience.

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.

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