Engineer - Biocompatibility & Regulatory

Job Description

Job Requirements Quest Global is seeking an experienced and highly skilled Lead Engineer: Biocompatibility to lead and support medical devices regulatory compliance efforts. The candidate shall have in-depth knowledge of global medical devices regulations, extensive experience in handling Biocompatibility requirements 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 Handling Biocompatibility safety gap assessment and Biological evaluation plan Ensure compliance with relevant standards and regulations, including ISO10993, ISO 13485, EU MDR, FDA, ISO 14971, IEC 62366 and other applicable country wise and global requirements Mentor and provide guidance to cross functional 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 compliance Provide guidance during product design and development to ensure compliance and minimize risks Work Experience Bachelor's or master’s degree in biomedical engineering, Mechanical Engineering, Electronics Engineering, or related fields. Advanced degrees are preferred. 2-4 years of experience in the medical devices industry Extensive knowledge on biocompatibility of medical device and submission processes Proven experience in working with ISO 10993, FDA, EU MDR and other global regulatory frameworks Strong understanding of medical device design, development, and manufacturing processes Expertise in technical writing and documentation preparation Strong analytical and problem-solving skills with the ability to interpret complex regulatory requirements Excellent leadership, communication, and collaboration skills