Regulatory Engineer

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Regulatory Engineer

My client are seeking a Regulatory Engineer to join their team in Alcester, Warwickshire. Experience of working with Medical Devices / Medical Technology is essential.

Job Description

Regulatory Engineer
Warwickshire, West Midlands

The company are a rapidly expanding Manufacturer who specialise in the design, development and manufacture of Medical Devices, an important asset to healthcare. They are looking for a Regulatory Engineer to provide technical support to the specialist regulatory team.

The ideal candidate for this position will need have experience of working with Medical Devices / Medical Technology so will be familiar with 13485, FDA and CFR regulations.

You will have previous experience of working within a position in which you have worked with cross functional teams across the business.

Key Responsibilities
- 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.

Requirements/Qualifications

- 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).
- High level of curiosity and attention to detail, with a methodical way of working.
- Ability to communicate effectively, and credibly, with all colleagues and stakeholders (internal & external).
- 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 plan and manage own workload.
- "Can do" attitude.
- Resilience and flexibility to work in a busy and changing environment.
- Willingness to learn and develop solutions to problems.
- To ensure good time keeping, punctuality and professional conduct at all times.
- To maintain good practice in the work environment.

Please Contact Cassie Moore for more information.

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