Job Requirements
At Quest Global, it's not just what we do but how and why we do it that makes us different. With over 25 years as an engineering services provider, we believe in the power of doing things differently to make the impossible possible. Our people are driven by the desire to make the world a better place—to make a positive difference that contributes to a brighter future. We bring together technologies and industries, alongside the contributions of diverse individuals who are empowered by an intentional workplace culture, to solve problems better and faster.
Overview
Quest Global is seeking an experienced and highly skilled
Quality and Regulatory Engineer to lead and support medical devices regulatory compliance efforts. The candidate shall have in-depth knowledge of global medical devices regulations, good experience on medical device quality management system, 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
- Conduct Quality audits.
- 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
- Develop medical device risk management file.
- 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
We wholeheartedly believe in the diversity of thought that comes with fostering a culture rooted in respect, where everyone belongs, is valued, and feels inspired to share their ideas. We know embracing our unique differences makes us better, and that solving the worlds hardest engineering problems requires diverse ideas, perspectives, and backgrounds. We shine the brightest when we tap into the many dimensions that thrive across over 21,000 difference-makers in our workplace.
Work Experience
Qualifications and Skills
- Bachelor's or Master's Degree in Biomedical Engineering, Mechanical Engineering, Electronics Engineering or related fields. Advanced degrees are preferred.
- 6-9 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
Benefits
As per Quest company policy
