Back to search
Regulatory Engineer - Medical Devices
Location:Buckinghamshire
Salary:45k-55k
Platform Recruitment is working with aleading medical device companyspecialising in thedesign, manufacture, and distributionof electro-mechanical medical devices. As part of their growth strategy, they are seeking an experiencedRegulatory Engineerto manage global regulatory compliance.
Key Responsibilities:
+ Ensure new products comply withEU MDR, UK MDR, FDA,and relevant standards
+ Support design teams withrisk analysis, regulatory compliance,and technical documentation
+ Produce, maintain, and reviewtechnical product filesfor Class I/IIa/IIb devices
+ Assist intransitioning productsto comply with evolving EU MDR regulations
+ Collaborate withinternal teams, regulatory authorities, and key stakeholders
Requirements:
+Degreein Engineeringor related technical field
+ Experience inmedical device developmentand regulatory compliance
+ Ability tointerpret standards and regulations
+ Proven experience writing documents forEU MDR, UK MDR, or FDA submissions
+ Knowledge ofrisk management (ISO 14971)andquality management systems (QMS)
Apply Now!
If you have the right skills and experience for thisRegulatory Engineer role, submit yourupdated CVtoday!
