Sr. Regulatory Affairs Specialist

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

Working independently under the direction of Regulatory Affairs Management, this position owns regulatory impact assessments and develops compliant, risk-based regulatory strategies across product development and lifecycle activities. The role requires strong collaboration with cross-functional partners and combines regulatory expertise, scientific knowledge, and business acumen to 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.

MAIN DUTIES/RESPONSIBILITIES

• 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, 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 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.

QUALIFICATIONS

Educational Requirements

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

Required 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.

Preferred Experience

• 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 Parts 11, 820, and 814
• EU MDR (EU) 2017/745
• ISO 13485 and ISO 14971
• IEC 60601, IEC 62304, and IEC 62366
• ISO 10993

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