Senior Analyst, Regulatory Affairs

Job Summary

The Senior Analyst, Regulatory Affairs is responsible for supporting regulatory intelligence and regulatory change management activities to help maintain compliance with global regulatory requirements. The role monitors emerging regulations, assesses potential impacts on products and business processes, and partners with cross-functional teams to support timely implementation of compliance actions. The position contributes to regulatory compliance programs that minimize business disruption, regulatory risk, and potential delays to product commercialization and distribution. This position reports to the Senior Manager, Regulatory Affairs and is part of the Global Quality Regulatory Affairs organization and will be an on-site role.

Responsibilities

• Monitor and track global regulatory developments affecting IVDs, medical devices, software, AI-enabled products, and chemical/environmental compliance frameworks (e.g., FDA, EU IVDR, REACH, RoHS, CLP, PFAS, EPA).
• Perform regulatory intelligence assessments and summarize regulatory changes, identifying potential impacts to products, processes, systems, and documentation. Maintain regulatory intelligence databases, dashboards, trackers, and communication tools.
• Prepare regulatory impact assessments and support regulatory change management activities, including tracking actions, maintaining compliance plans, and facilitating implementation with cross-functional stakeholders. Develop and deliver periodic regulatory intelligence reports and presentations for management review.
• Leverage digital and AI-enabled tools to improve regulatory monitoring, trend analysis, and knowledge management processes.
• Support inspections, audits, and compliance initiatives by providing regulatory intelligence and change management documentation.

Essential Requirements

• Bachelors degree in Life Sciences, Engineering, Regulatory Affairs, or a related field; Masters degree preferred. 5+ years of experience in Regulatory Affairs, Regulatory Intelligence, Quality, Compliance, or related functions within the medical device or IVD industry.
• Working knowledge of global medical device and IVD regulations, including FDA regulations, EU IVDR, ISO 13485, and applicable regulatory guidance.
• Experience conducting regulatory assessments and translating regulatory requirements into actionable business recommendations and managing or supporting compliance-related projects in a cross-functional environment.
• Strong analytical, communication, and project management skills.
• Experience using regulatory intelligence platforms, compliance databases, or digital tools.

Preferred qualifications

• Experience with AI/software regulations, cybersecurity regulations, or chemical/environmental compliance requirements.
• Experience supporting audits, inspections, or interactions with regulatory authorities and notified bodies.
• Experience leveraging AI or automation tools to improve regulatory intelligence workflows.

Work Arrangement

This position is eligible for a remote work arrangement in which you can work remotely from your home.

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