Regulatory Engineer

Regulatory Engineer - Medical Devices
Location: Buckinghamshire
Salary: 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!