Technical Lead -R&D Regulatory (USFDA, EUMDR) - Medical Devices

Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy. Participates in advocacy activities of a more advanced strategic nature
· Develops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies
· Provides guidance to integrate regulatory considerations into global product entry and exit strategy
· Works with little to no supervision or instruction. Expected to take on leadership role on significant projects. Acts as divisional technical mentor / lead of others in department. Demonstrates advanced technical leadership skills and influence outside of department
· Makes informed decisions based on business frameworks and tools and give consideration to risks tradeoffs, timing, and available resources
· Identifies regulatory pathways for initial product designs and provides input to internal stakeholders
· Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes
· Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles
· Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations
· Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy)
· Negotiates with regulatory authorities on complex issues throughout the product lifecycle