Regulatory Affairs Specialist

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. Our focus on patient outcomes is at the core of everything we do, and our “think I can” attitude drives us to make a difference in the lives of those seeking alternative sleep apnea treatments.   

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! 

ABOUT THIS POSITION  

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, and 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. 

WHAT YOU CAN BRING TO OUR GREAT TEAM

Required: 

• Bachelor’s degree
• 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.:
  1. FDA
  2. EU Notified Body
  3. PMDA
  4. TGA
• Education and/or work experience in a technical or scientific field
• Experience working in the medical device industry

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, 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.