Lead Regulatory Engineer

Quest Global is seeking an experienced and highly skilled Lead Regulatory Engineer to lead and support medical devices regulatory compliance efforts. The candidate shall have in-depth knowledge of global medical devices regulations, extensive experience in preparing and managing regulatory submissions and a strong ability to guide cross-functional teams in meeting compliance requirements. This role involves leadership, technical expertise and strategic thinking to ensure successful product approvals and lifecycle management.

Roles and Responsibilities

• Develop, prepare and oversee regulatory submissions (eg. 510(k), PMA, CE Mark, Health Canada and other international filings) for new and existing products

• Ensure 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 requirements

• Knowledge in eSTAR submissions, Medical Device Cybersecurity and EU AI act

• Review and approve technical files, design dossiers, and product documentation to support regulatory approvals

• Act as the regulatory lead in cross-functional teams, including R&D, Quality Assurance, Marketing and Manufacturing

• Mentor and provide guidance to Regulatory Engineers and other team members

• Ensure compliance of verification, validation and testing protocols with applicable standards

• Review risk management documentation and clinical evaluations to ensure regulatory compliance

• Provide strategic regulatory guidance during product design and development to ensure compliance and minimize risks

• Bachelor's or master degree in biomedical engineering, Mechanical Engineering, Electronics Engineering or related fields. Advanced degrees are preferred.

• 9-15 years of regulatory experience in the medical devices industry

• Extensive knowledge of device regulations and submission processes

• Proven experience in working with FDA, EU MDR and other global regulatory frameworks

• Strong understanding of medical device design, development and manufacturing processes

• Expertise in technical writing and regulatory documentation preparation

• Strong analytical and problem-solving skills with the ability to interpret complex regulatory requirements

• Excellent leadership, communication and collaboration skills