Quality and Regulatory Lead

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 Quality and Regulatory Lead with 10 – 15 years of experience in the medical devices industry to lead and oversee regulatory activities. In-depth understanding of medical device quality management system. 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. Role requires strong understanding of medical device manufacturing process and quality systems.

Roles and Responsibilities

·       Lead and mentor a team of quality and regulatory professionals, fostering a culture of excellence and continuous improvement

·       Provide guidance on complex regulatory issues and training on new regulations

·       Develop and execute global regulatory strategies to support product approvals and market access

·       Conduct quality audits of R&D and Manufacturing plant.

·       Collaborate with cross-functional teams (R&D, Quality, Marketing etc.) to ensure alignment of regulatory requirements with business goals of the client

·       Manage interactions with regulatory authorities to facilitate timely approvals

·       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

·       Manage regulatory impact assessments for design and manufacturing changes

·       Oversee regulatory activities for product updates, labeling changes and post-market surveillance

·       Monitor and interpret evolving regulations to anticipate and manage changes

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

We are known for our extraordinary people who make the impossible possible every day. Questians are driven by hunger, humility, and aspiration. We believe that our company culture is the key to our ability to make a true difference in every industry we reach. Our teams regularly invest time and dedicated effort into internal culture work, ensuring that all voices are heard.

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.

Qualifications and Skills

·       Bachelor's or Master’s Degree in Biomedical Engineering, Mechanical Engineering, Electronics Engineering or related fields. Advanced degrees are preferred.

·       10-15 years of regulatory experience in the medical devices industry, with a proven track record of successful submissions and approvals

·       Strong knowledge of global regulatory frameworks, including US FDA, EU MDR, Health Canada, TGA etc.

·       Strategic thinking with a deep understanding of regulatory affairs

·       Excellent leadership, project management and communication skills

·       Ability to interpret and apply complex regulatory requirements effectively

·       Relevant certifications such as RAC or equivalent are highly desirable

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