Regulatory Affairs Specialist

About This Role

This role involves creating, evaluating, and completing regulatory tasks for worldwide product registration submissions, facility registrations, special projects, and strategy to drive market growth globally. The specialist is responsible for obtaining global regulatory registrations and approvals based on company objectives, attending product development meetings, and collaborating with cross-functional departments to ensure country-specific requirements are met throughout the design control and post-product launch activities.

Responsibilities

• Assemble and maintain CE technical files in accordance with applicable regulatory requirements
• Author, review, and approve Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), Periodic Safety Update Reports (PSUR), and Post-Market Surveillance (PMS) reports
• Monitor and interpret regulatory changes, including proposed and final rules issued by global regulatory authorities, and assess their impact on company operations
• Develop and maintain procedures, standard operating procedures (SOPs), and technical documentation to support regulatory compliance and operations
• Collaborate with global registration teams to support product registrations across a diverse portfolio, ensuring alignment with country-specific requirements
• Implement and coordinate regulatory strategies and plans as directed by senior leadership, ensuring timely and compliant product registrations
• Prepare, submit, and maintain regulatory submissions, product registrations, certifications, and facility registrations for global markets
• Liaise with distributors, in-country consultants, inter-company partners, and commercial teams to fulfill regulatory requirements for product registration and compliance
• Review and evaluate product, manufacturing, and labeling changes to determine regulatory reporting obligations and ensure continued compliance
• Serve as a strategic regulatory partner, providing guidance on complex compliance landscapes and facilitating global product approvals
• Uphold and integrate Envista CIRCLe values into daily work, fostering customer-centric and ethical relationships with internal and external stakeholders
• Stay informed of new regulatory developments by reviewing relevant publications and industry updates
• Perform special projects and assignments as directed by Manager

Requirements

• Bachelor's Degree
• 2+ years of Regulatory Affairs experience in medical devices or other regulated industry (or Master’s Degree with 1+ years of Regulatory Affairs experience in medical devices or other regulated industry)
• Strong working knowledge of the European Medical Device Regulation (EU MDR), including demonstrated experience with Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), Post-Market Surveillance (PMS), and Periodic Safety Update Reports (PSUR)