Senior Regulatory Affairs Specialist (Senior IC or Manager) at Lexington Medical, Inc.

This role involves overseeing and managing regulatory affairs activities for medical devices, ensuring compliance with global regulations. The Senior Regulatory Affairs Specialist will be responsible for developing and implementing regulatory strategies, preparing and submitting regulatory documentation, and liaising with regulatory agencies. The position requires a deep understanding of regulatory requirements for medical devices, including those for minimally invasive surgical stapling solutions. The role may involve leading a team or functioning as a senior individual contributor, depending on the specific track. Key aspects of the role include navigating complex regulatory landscapes, ensuring product approvals and market access, and contributing to the company's product development and lifecycle management. The specialist will work closely with cross-functional teams, including R&D, quality assurance, and manufacturing, to ensure that all regulatory requirements are met throughout the product lifecycle. This position demands a proactive, diligent, and resourceful individual who can drive compliance and support business objectives.