Sr. Regulatory Affairs Specialist

The role

The Senior Regulatory Affairs Specialist will lead and execute regulatory strategy for an implantable neurostimulation therapy for obstructive sleep apnea. This role supports global regulatory activities with a primary focus on the United States and European Union.

What you will do

• Serve as a strategic regulatory partner to product development, operations, quality, clinical, manufacturing, and marketing teams.
• Assess regulatory impact for new product development and post-market product changes.
• Develop and communicate regulatory pathway options and recommendations.
• Compile, prepare, review, and submit regulatory submissions in the U.S. and EU.
• Collaborate with subject matter experts to prepare responses to regulatory authority questions.
• Review and approve product development, operations, labeling, clinical, and software documentation.
• Maintain accurate regulatory files, submissions, and tracking systems.
• Manage multiple projects simultaneously.
• Complete all required training and maintain competency.
• Comply with applicable Quality System procedures and regulatory requirements.

Required qualifications

• 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

Nice to have

• 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 Active implantable medical devices
• Regulatory support experience in Software regulated as a medical device or software as part of a medical device
• Regulatory support experience in Manufacturing or supplier changes
• Working knowledge of 21 CFR Parts 11, 820, and 814
• Working knowledge of EU MDR (EU) 2017/745
• Working knowledge of ISO 13485 and ISO 14971
• Working knowledge of IEC 60601, IEC 62304, and IEC 62366

Benefits

• 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
• Equity awards
• Employee Stock Purchase Program

About the company

Inspire Medical Systems is a company with an FDA-approved medical device designed to reduce OSA severity. They are committed to enhancing patients' lives through sleep innovation.