Principal Regulatory Affairs Manager

Responsibilities

• Develop and execute regulatory strategy for external partnerships and product lifecycle management, ensuring compliance with global requirements and state-of-the-art standards.
• Maintain regulatory intelligence and execute regulatory plans, and ensure internal procedures are updated to reflect evolving US and international regulations.
• Assess the impacts of relevant drug and diagnostic regulations on the development and registration activities for the respective medical products.
• Develop and manage regulatory submissions (e.g., 510(k), PMA, EU Technical Files, STED), including documentation, timelines, and agency interactions to secure product approvals.
• Collaborate cross-functionally and globally with Clinical Affairs, R&D, QA, and Business Development to align regulatory plans with, and provide inputs and updates to, business and clinical goals.
• Provide device-specific regulatory insight/guidance during CDx / Pharma partner cross-functional meetings.

Requirements

• Bachelor's, Master's, or PhD in a scientific or engineering discipline.
• In-depth working knowledge of FDA and EU regulatory requirements for Companion Diagnostics (CDx) devices.
• Extensive experience working with cross functional teams developing companion diagnostics and devices.
• Substantial experience developing and executing regulatory strategies for high-complexity diagnostic products, including 510(k) and PMA submissions.
• Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required.
• Good understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process.
• Applying advanced regulatory expertise to support the global development and commercialization of complex, high-risk products, with a focus on both immediate challenges and long-term strategic outcomes.
• Leading cross-functional teams in a matrixed environment, ensuring timely decision-making, issue resolution, and alignment across global and culturally diverse stakeholders.
• Experience with drug development and drug regulatory procedures.