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 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 Regulatory Affairs Specialist will provide regulatory support for a first of its kind, implantable neurostimulation therapy for the treatment of obstructive sleep apnea. This role will initially focus on manufacturing change assessments and submissions in the US and Europe, annual reports, labeling and promotional material reviews. Additionally, this role will have opportunity to gain a broader range of regulatory experience with design change and new product development submissions in the US and internationally.

OPPORTUNITIES YOU WILL HAVE IN THIS ROLE

• Conduct regulatory assessments of design and manufacturing changes, e.g., engineering change orders and supplier change requests.
• Develop annual report submissions, as well as submissions for manufacturing changes in the US and EU, e.g., PMA 30-Day Notices, design dossier amendments, and other geographies as assigned.
• Work with technical experts in product development, quality, and clinical to address questions from regulatory agencies.
• Interact directly with FDA and international 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.

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.
• Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.

WHAT YOU CAN BRING TO OUR GREAT TEAM

Required:

• Bachelor's degree
• Required Experience
• 2+ years medical device industry experience, preferably in regulatory, quality, and/or engineering.

Preferred:

• Regulatory compliance experience, e.g., regulatory assessment of design and manufacturing process changes
• Regulatory submission experience, e.g.
• FDA
• EU Notified Body
• PMDA
• TGA
• Education and/or work experience in a technical or scientific field
• Experience working in the medical device industry

#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.

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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