Senior Manager, Regulatory Affairs – MedTech

• Own regulatory decision-making and strategy for assigned product lines, projects, regions, or regulatory initiatives involving significant complexity or regulatory risk
• Prepare, author, coordinate, or provide senior technical oversight for U.S. and/or international regulatory submissions, including responses to regulatory agency questions
• Approve regulatory strategies developed by Managers and below
• Represent Regulatory as the senior Regulatory Affairs lead on assigned product/project teams and align worldwide regulatory strategies with business objectives
• Maintain communications within Regulatory and across functions to align technical positions, escalation decisions, and consistent execution
• Provide strategic and technical input for product development, project plans, and business decisions
• Monitor evolving regulatory requirements, assess impacts on assigned products/projects or technologies, and ensure compliance
• Review and approve product labeling and advertising/promotional materials for regulatory compliance
• Support regulatory activities for government tenders/initiatives, including professional certifications if required
• Ensure post-market regulatory compliance, including annual reports, PADERs, PSURs, and PMS/PMCF reports where applicable
• Lead complex Health Authority interactions, including meetings, negotiations, and responses
• Develop and maintain effective relationships with regulatory agencies
• Mentor and train other regulatory team members

• Bachelor's Degree
• 8+ years of experience in a regulatory function
• Strong technical, regulatory, and problem-solving skills
• Understanding of device and/or drug regulatory requirements, their foundation, and submission processes
• Demonstrated experience providing and executing complex regulatory strategies and/or managing novel regulatory challenges
• Advanced interpersonal skills and ability to manage conflict situations and influence stakeholders
• Proven effective collaboration with regulatory agencies
• Experience with infusion systems, transfusion technologies, cellular therapies, or drugs preferred
• Ability to effectively speak, read, write, and understand English
• Must be able to independently understand policies, procedures, training materials, and workplace communications written in English
• Position is not eligible for visa sponsorship now or in the future

Demonstrates extensive experience in regulatory decision-making and strategy, with a strong focus on compliance and effective collaboration with regulatory agencies. Capable of leading complex regulatory submissions and providing strategic input for product development and business decisions.

• Regulatory Strategy Development
• Regulatory Submissions Oversight
• Regulatory Compliance Monitoring
• Interpersonal Skills
• Experience with Infusion Systems

• Regulatory Decision-Making
• Regulatory Submissions
• Regulatory Compliance
• Problem-Solving Skills
• Understanding of Regulatory Requirements
• Complex Regulatory Strategies
• Post-Market Regulatory Compliance
• Health Authority Interactions
• Product Labeling Review
• Technical Oversight

• Advanced Interpersonal Skills
• Conflict Management
• Stakeholder Influence
• Effective Collaboration

• Device Regulatory Requirements
• Drug Regulatory Requirements
• Infusion Systems
• Transfusion Technologies
• Cellular Therapies
• Government Tenders
• PADERs
• PSURs
• PMS/PMCF Reports
• Regulatory Agency Relationships