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Regulatory Engineer, Medical Devices - UK - 6 Month Contract

Eingestellt von Optimus Search

Gesuchte Skills: Engineer, Support

Projektbeschreibung

REGULATORY ENGINEER, MEDICAL DEVICES - UK - 6 MONTH CONTRACT - COMPETITIVE

Optimus Search are working with an innovative UK based medical device company who have been in the process of constant expansion. They manufacture a complex electro-mechanical device and are looking at recruiting someone to help with the regulatory load required for entry in to the USA market through the 510(k) process as well as other markets.

Ideal candidates will be adept regulatory professionals with experience which includes Programmable Electrical Medical Systems (PEMS), this doesn't necessarily mean experience with BS EN 60601-1 and collateral standards but this would be a help. Experience with the software standards and classification of these with respect to medical devices will also be useful.

TASKS

- Participate in working on (and the maintenance of) Technical Files for the companies CE status.
- Provide input relating to Regulatory Compliance when entering into new markets - including strategy, market specific QMS requirements and ensuring the relevant documentation is correct and properly maintained.
- To provide support with the application for the FDA 510(k) process.
- Provide regulatory advice and training to colleagues regarding future changes to the MDD.

REQUIREMENTS

- A relevant Degree/proven industry experience.
- Experience with medical devices and the 510(k) process.
- Experience with the construction and maintenance of a Technical File as required for CE.
- Experience with the implementation of the MDD.

If you want to know more about the position please send an updated CV to (see below) and we can set up a call.

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Optimus Search