Regulatory Engineer

Regulatory Engineer - Medical Devices

Location: BuckinghamshireSalary: £45k-£55k

Platform Recruitment is working with a leading medical device company specialising in the design, manufacture, and distribution of electro-mechanical medical devices. As part of their growth strategy, they are seeking an experienced Regulatory Engineer to manage global regulatory compliance.

Key Responsibilities:

+ Ensure new products comply with EU MDR, UK MDR, FDA, and relevant standards+ Support design teams with risk analysis, regulatory compliance, and technical documentation+ Produce, maintain, and review technical product files for Class I/IIa/IIb devices+ Assist in transitioning products to comply with evolving EU MDR regulations+ Collaborate with internal teams, regulatory authorities, and key stakeholders

Requirements:

+ Degree in Engineering or related technical field+ Experience in medical device development and regulatory compliance+ Ability to interpret standards and regulations+ Proven experience writing documents for EU MDR, UK MDR, or FDA submissions+ Knowledge of risk management (ISO 14971) and quality management systems (QMS)

Apply Now!If you have the right skills and experience for this Regulatory Engineer role, submit your updated CV today!