|Job Title:||Regulatory Engineer|
|Location:||Birmingham, West Midlands|
|Salary:||£30000 - £35000 per annum|
|Contact Name:||Rachel Radford|
|Job Published:||March 27, 2017 10:34|
As a Regulatory Engineer you will provide technical support to the Technical Regulatory Specialist and the Regulatory Strategy Specialist in the area of Regulation.
Your responsibilities will include, but not be limited to:
- To maintain the biocompatibility records for the materials and process being used in the manufacture of the SC+ Device.
- To undertake vigilance activities to support PMS requirements.
- To aid with regulatory compliance in other markets to which devices manufactured by the company will be introduced.
- To provide support with the application for the FDA 510(k) process.
- To provide assistance in the application of market specific QMS requirements e.g. ISO 13485, FDA 21 CFR Part 820 etc.
- To ensure that all standards associated with devices manufactured by the company are maintained to the latest issue.
- To provide support to the risk process (BS EN ISO 14971) for TF maintenance and FDA submission.
- A relevant degree (2:1 or higher), Masters or PhD involving a high level of research, data interpretation, and presentation preferably in Science or Engineering.
- Experience with the Medical Device Directive and the particular standards associated with Sterilisation and Biocompatibility of medical devices.
- An ability to use general office software (Microsoft Office) and other specialised software (e.g. online resource tools and databases).
- Excellent communication skills
- Ability to analyse and understand data to enable decisions to be made objectively.
- Ability to follow instructions accurately and diligently.
- Attention to detail is essential.
- Ability to work autonomously.
For a confidential discussion about this role please call Rachel on +44 (0) 2033273072 or send your CV to firstname.lastname@example.org.
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