Cure Talent is delighted to be working with an innovative MedTech company revolutionising ear and hearing healthcare! With their ongoing growth and exciting projects, we have a fantastic opportunity for a Regulatory Engineer to join their highly motivated team on an initial 9 month fixed term contract.
This newly created role is key to ensuring the successful regulatory approval of new and existing medical devices, working closely with internal teams and subcontractors.
As their Regulatory Engineer, you will be responsible for managing regulatory activities, ensuring compliance with ISO 13485, EU MDR, and FDA requirements, and compiling technical documentation for regulatory submissions. You will collaborate with design and manufacturing partners to oversee risk management, biocompatibility assessments, and design control processes.
Work with internal teams and subcontractors to ensure product compliance with ISO 13485, EU MDR, and FDA regulations
Manage regulatory activities related to medical device development, including risk management, biocompatibility, and design verification
Produce and compile regulatory documentation, including technical files and submission documents for the FDA
Oversee and maintain regulatory documentation within the company’s eQMS
Review device history records (DHRs), batch acceptance reports, and other quality-related documentation
BSc in Engineering or a related field.
Proven experience in Regulatory Affairs in Medical Devices
Proficiency in risk management processes, including ISO 14971