Meera Pattni at CK Regulatory is recruiting for a Regulatory Affairs Engineer to be based in West Sussex.
The role:
As Regulatory Affairs Engineer, you will support the Quality and Regulatory Affairs Manager in achieving regulatory goals and objectives by proactively supporting the organisation in achieving the necessary regulatory submissions for the targeted markets. In addition, you will also be required to develop and maintain worldwide regulatory knowledge in the preparation of regulatory submissions and registrations.
Main responsibilities:
- Identify and provide advice and guidance on worldwide regulations throughout the organisation to ensure that up to date knowledge is maintained and implemented.
- Control the preparation and maintenance of submissions to regulatory authorities for all targeted markets.
- Collaborate with Compliance Engineers to provide Regulatory advice and guidance.
- Support Business Units and Distributors world wide during the tendering process byproviding supporting documentation and certification including Manufacturers Declarations.
- Provide regulatory determinations when required by CFR committees.
- Perform regulatory review on business documentation.
- Liaise with regulatory authorities.
- Advise on installation issues relating to new product development and the installed base.
The ideal candidate:
Meera is looking for candidates with the following skills and experience:
- Ability to interpret, adapt and provide guidance on product registration.
- Proven track record in regulatory affairs.
- Good communication skills.
- Previous experience within medical devices.
How to apply:
For more information or to apply for this Regulatory Affairs Engineer position, please contact Meera on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL22950 in all correspondence.
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