Senior 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. 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! 

• Serve as a strategic regulatory partner to product development, operations, quality, clinical, manufacturing, and marketing teams, providing clear guidance on regulatory requirements and risks.


• Independently assess regulatory impact for new product development and post-market product changes, including design, manufacturing, labeling, and supplier changes. 


• Develop and communicate regulatory pathway options and recommendations aligned with business objectives and global regulatory expectations.


• Compile, prepare, review, and submit high-quality regulatory submissions in the U.S. for PMA, IDE, supplements, and amendments, and EU for MDR Class III Technical Documentation, design change, notified body responses.


• Collaborate with subject matter experts to prepare accurate, timely, and professional responses to regulatory authority questions.


• Review and approve product development, operations, labeling, clinical, and software documentation to ensure regulatory compliance and submission readiness.


• Maintain accurate regulatory files, submissions, and tracking systems across the product lifecycle.


• Manage multiple projects simultaneously, maintaining high attention to detail, accountability, and execution quality.

• Complete all required training and maintain competency for assigned responsibilities. 


• Comply with applicable Quality System procedures and regulatory requirements. 


• Identify opportunities for continuous improvement in regulatory processes, tools, and documentation practices.

• Bachelor’s degree in engineering, life sciences, or related scientific discipline (or equivalent experience)

• 5+ years of experience in a regulated industry with transferable skills to medical devices. 


• Strong technical writing, communication, and stakeholder‐management skills.


• Demonstrated ability to work independently on regulatory assessments and submissions.

• Medical device industry experience, in regulatory affairs, quality, and/or engineering.


• Direct experience with pre- and post-market medical device submissions such as 510(k), IDE, PMA supplements, Pre-submissions, EU Technical Documentation and NB interactions.


• Experience interacting directly with regulatory authorities. e.g., FDA, Notified Bodies, or Competent Authorities. 


• Regulatory support experience in one or more of the following areas:
  
  
  
  • Active implantable medical devices
  
  
  • Software regulated as a medical device or software as part of a medical device
  
  
  • Manufacturing or supplier changes
  
  
  
  


• Working knowledge of applicable regulations and standards:
  
  
  
  • 21 CFR Part 11, 820, 814
  
  
  • EU MDR (EU) 2017/745
  
  
  • ISO 13485, ISO 14971
  
  
  • IEC 60601, IEC 62304, IEC 62366
  
  
  • ISO 10993
  
  
  
  

#LI-Onsite

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.