Job Requirements

Overview

Quest Global is seeking an experienced Regulatory Affair with 10+ years of experience in the medical devices industry to lead and oversee regulatory activities. This role requires strong technical and regulatory knowledge. They ensure compliance with global regulations, manage product approvals and guide the clients in meeting regulatory requirements throughout the product lifecycle.

Roles and Responsibilities

Lead and mentor a team of regulatory/remediation engineers, fostering a culture of excellence and continuous improvementProvide guidance on complex regulatory issues and training on new regulationsDevelop and execute global regulatory strategies to support product approvals and market accessCollaborate with cross-functional teams (R&D, Quality, Marketing etc.) to ensure alignment of regulatory requirements with business goals of the clientManage interactions with regulatory authorities to facilitate timely approvalsEnsure compliance with relevant standards and regulations, including ISO 13485, EU MDR, FDA 21 CFR 820, QMSR, ISO 14971, IEC 62304, IEC 62366 and other applicable country wise and global requirementsManage regulatory impact assessments for design and manufacturing changesOversee regulatory activities for product updates, labeling changes and post-market surveillanceMonitor and interpret evolving regulations to anticipate and manage changesEnsure compliance of verification, validation and testing protocols with applicable standards

Work Experience
Bachelor's or master’s degree in biomedical engineering, Mechanical Engineering, Electronics Engineering or related fields. Advanced degrees are preferred.8+ years of regulatory experience in the medical devices industry, with a proven track record of successful submissions and approvalsStrong knowledge of global regulatory frameworks, Primarily US FDA, EU MDR.Secondary Knowledge on Health Canada, TGA, CDSCO etc .Strategic thinking with a deep understanding of regulatory affairsExcellent leadership, project management and communication skillsAbility to interpret and apply complex regulatory requirements effectively