Sr. Regulatory Affairs Specialist

Inspire Medical Systems Inc.•Minneapolis, MN

7h•$11,000 - $150,000•Onsite

About The Position

The Senior Regulatory Affairs Specialist will lead and execute regulatory strategy for an implantable neurostimulation therapy for obstructive sleep apnea, supporting global regulatory activities with a primary focus on the United States and European Union. Working independently under the direction of Regulatory Affairs Management, this role owns regulatory impact assessments and develops compliant, risk-based strategies across product development and lifecycle activities. It combines regulatory expertise, scientific knowledge, and business acumen to help ensure products are developed, manufactured, and maintained in compliance with applicable global regulatory requirements. Experience supporting software-enabled or software-driven medical devices is strongly preferred.

Requirements

Bachelor's degree in engineering, life sciences, or a related scientific discipline, or equivalent experience.
At least 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 Haves

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 notified body interactions.
Experience interacting directly with regulatory authorities, such as the FDA, Notified Bodies, or Competent Authorities.
Regulatory support experience with active implantable medical devices.
Regulatory support experience with software regulated as a medical device or software that is part of a medical device.
Regulatory support experience with manufacturing or supplier changes.
Working knowledge of 21 CFR Parts 11, 820, and 814; EU MDR (EU) 2017/745; ISO 13485 and ISO 14971; IEC 60601, IEC 62304, and IEC 62366; and ISO 10993.
Experience supporting software-enabled or software-driven medical devices.

Responsibilities

Serve as a strategic regulatory partner to product development, operations, quality, clinical, manufacturing, and marketing teams, providing 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 U.S. regulatory submissions for PMA, IDE, supplements, and amendments, and EU MDR Class III Technical Documentation, design changes, and 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 for regulatory compliance and submission readiness.
Maintain accurate regulatory files, submissions, and tracking systems across the product lifecycle.
Manage multiple projects simultaneously while maintaining attention to detail, accountability, and execution quality.
Complete required training and maintain competency for assigned responsibilities.
Comply with applicable Quality System procedures and regulatory requirements.
Identify opportunities to improve regulatory processes, tools, and documentation practices.