The Device Regulatory Affairs Submission Manager is responsible for leading the planning, preparation, coordination, and submission of regulatory dossiers for medical devices and combination products throughout the product lifecycle. This experienced professional partners with Regulatory Affairs leadership and cross-functional teams to drive submission execution, ensure high-quality deliverables, and maintain compliance with applicable regulatory requirements and company procedures. The role requires deep knowledge of device submission processes, strong project management skills, and the ability to train and mentor junior staff. This position ensures submissions are accurate, complete, compliant with global regulatory requirements, and delivered on time to support product development, approvals, lifecycle maintenance, and post-market activities. The role also requires close collaboration with teams in R&D, Quality, Clinical, Manufacturing, and external publishing vendors.

Key Responsibilities

• Independently leads planning, preparation, review, and submission of regulatory dossiers for medical device products and lifecycle changes. Coordinate submission strategies and timelines across internal stakeholders to support global market access.
• Demonstrates a deep understanding of medical device regulatory requirements, including global submission pathways, applicable standards, and lifecycle expectations, and applies this knowledge to ensure compliant, high-quality submission strategy and execution.
• Acts as primary RA Submissions interface with project teams providing guidance and communication of established submission processes, standards and technical specifications. Plans and negotiates submission project scope, publishing timelines and deliverable
• Compile, review, and publish high-quality submission documents, including technical files, variation packages, amendments, and responses to health authority questions, ensuring all submissions are accurate, complete, and compliant with applicable regulations, standards, and company procedures.
• Manage preparation of submission structures, Track submission status, identify risks, and escalate issues that may impact timelines or approval outcomes.
• Maintain awareness of evolving regulations, guidance, and submission requirements for relevant markets.

• Maintain submission trackers, regulatory databases, and document control systems.
• Collaborate with cross-functional teams to gather technical, quality, clinical, and labeling information needed for submissions.
• Identify gaps and contribute to process improvement initiatives and best practices for submission management to enhance submission efficiency, quality, and compliance.