Regulatory Affairs Engineer

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. 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.

Key Responsibilities:

• 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 Notified Bodies and regulatory authorities
• Oversee and maintain regulatory documentation within the company’s eQMS
• Review device history records (DHRs), batch acceptance reports, and other quality-related documentation
• Generate and maintain UDI records for new production runs

The Ideal Candidate Will Have:

• BSc in Science or a related field
• Proven experience in Regulatory Affairs in Medical Devices
• Experience in the compilation of technical files for FDA Submissions (De Novo, Q Sub, 510(k), PMA)
• Knowledge of ISO 13485, EU MDR, and FDA requirements
• Proficiency in risk management processes, including ISO 14971

If you're looking for an exciting opportunity to be part of a rapidly expanding company at the forefront of health technology innovation, get in touch today!