Regulatory Engineer- Medical Devices

2 weeks ago


Caerphilly Caerphilly, United Kingdom Focus Resourcing Group Full time

The main responsibilities involve the biological safety risk assessment, by chemical analysis and characterisation, of medical devices in development.
You develop protocols, reports, and regulatory summaries in collaboration with cross-functional teams, laboratories and suppliers.
Management of external test laboratories and ensure compliance with global regulatory requirements and standards related to biological safety.
You are also entrusted with defining testing strategies for materials, design and process that satisfy cost and technical requirements as well as analysing bio-compatibility testing (
Review and approves external chemical analysis reports
Bachelor's degree or higher in Biochemistry, Chemistry, Chemical Engineering, (Bio)Medical Engineering or Physics.
In-depth knowledge of quality assurance techniques, practices, ISO and Regulatory (FDA) compliance.
In-depth knowledge of medical device regulations and standards
Ability to define problems, collect and analyse data, establish facts, and draw valid conclusions.
Actively network with the internal and external scientific, technical, and regulatory community to maintain state of the art knowledge.
Partner with Quality to support the development, maintenance and adherence to quality systems and continuous process improvement.
Partner with product development and regulatory functions to ensure new and sustaining products meet all necessary requirements.
o 25 days holiday (plus bank holidays)
o Pension - salary sacrifice (3% ER / 5% EE)
o Annual company performance bonus
o Annual pay review
o Benefits - Health cash plan, income protection, life assurance (2 x salary), holiday trading, monthly benefit fund to use or put in pension pot



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