What are the responsibilities and job description for the International Regulatory Affairs Specialist position at Inspire Medical Systems I?
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 :
Preferred :
SALARY
The salary for this position is expected to be between ( $74,700 - $101,100 ) and 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.
BENEFITS AND OTHER COMPENSATION
Inspire offers a highly competitive benefits package including ( general description of the benefits and other compensation offered ) :
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.
Salary : $74,700 - $101,100
