Job Description:

Provide regulatory support for neurostimulation therapy for the treatment of obstructive sleep apnea in adult and pediatric patients. Focus on US and international regulatory submissions and evaluate market access requirements for new geographies in Asia and Latin America, e.g., India, Brazil, and others as required. Conduct regulatory assessments of design and manufacturing changes, e.g. engineering change orders and supplier change requests. Assist with manufacturing and design changes and new product development submissions, as well as conducting gap assessments between Inspire’s US and EU regulatory documentation and the regulatory requirements in new geographies.  Interact directly with 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.

Job Requirements:

1. Bachelor’s degree in engineering, pharmacy, or relevant scientific field.
2. Five (5) years of progressive experience in Regulatory Affairs or a related discipline in the medical device industry.
3. Two (2) years of experience specifically in Regulatory Affairs, which may have been gained as part of or in addition to the required progressive experience.
4. Experience must include:
   1. US Class III devices.
   2. Authoring a variety of regulatory submissions for US and EU related to implantable devices.
   3. Basic submission processing experience with submission portal use and fee processing systems
   4. Microsoft Word, Excel, PowerPoint and Adobe Acrobat.
5. Must have current authorization to be employed in the U.S. without employer sponsorship.

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• 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

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