Manager, Regulatory Affairs

Role Overview

• Develop and execute global, regional, and multi‑country regulatory strategies aligned with enterprise and product portfolio objectives, considering evolving global, societal, economic, and regulatory trends
• Lead regulatory pathway planning across the product lifecycle, including product design, development, market entry, expansion, and exit strategies
• Provide strategic regulatory guidance to cross‑functional teams (R&D, Quality, Clinical, Supply Chain, Marketing, and Commercial) to ensure compliant, efficient product development and market access
• Assess regulatory risks, safety considerations, and market access barriers, including reimbursement and distribution requirements, and drive solutions to mitigate potential obstacles
• Lead complex negotiations and interactions with global regulatory authorities, advocacy groups, and government and non‑government organizations throughout development, approval, and post‑market phases
• Oversee regulatory submissions, inspections, and agency interactions, including eCTD management, advisory committees, and pre‑approval, GCP, and clinical investigator inspections
• Monitor and adapt regulatory strategies in response to changing regulations, ensuring compliance and optimizing pre‑approval and post‑approval approaches, including accelerated pathways where applicable
• Establish and maintain regulatory policies, procedures, SOPs, and training programs to ensure organizational compliance and continuous improvement
• Manage and develop a high‑performing regulatory team, including talent acquisition, performance management, goal setting, budgeting, forecasting, metrics, and stakeholder engagement

Requirements

• Required Bachelor of Science in Science or Engineering
• Minimum of 8+ years’ experience in an FDA-regulated industry with demonstrated experience in leading regulatory pathway planning across the full product lifecycle (development through market entry, expansion, and exit)
• Minimum of 3+ years of people leadership experience, including recruiting, talent development, team performance management, and demonstrated process improvement and operational management skills
• Demonstrated technical expertise across medical device product lines, with strong working knowledge and application of ISO, FDA, and global regulatory requirements
• Preferred Master's Degree or equivalent preferred RAC certification or related certification desired
• Demonstrated ability to prioritize and manage multiple projects simultaneously, leveraging data trending and analysis to influence decisions and outcomes across the organization

Tech Stack

• Google Cloud Platform

Benefits

• None listed