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Regulatory Affairs Specialist

  • Location:

    Winsford

  • Contact:

    Nathan Blake

  • Job ref:

    4881

  • Published:

    about 1 month ago

  • Expiry date:

    2021-09-16

Are you a Regulatory Affairs Specialist looking for an exciting new opportunity? Do you want to work for a growing Medical Device organisation that are rapidly growing and creating new products? Are you looking to work in a state-of-the-art facility? If so this may be the opportunity that you have been searching for…

 

The responsibilities of the Regulatory Affairs Specialist will be as follows:

 

  • Maintain regulatory technical documentation, 510K files

  • Development of new product regulatory strategy documents

  • Generate and submit high quality regulatory compliant documentation for products into USA & Europe to make sure pre-market approvals are achieved

  • Maintain current registrations, licences, and regulatory certification

 

What you will need to do the job:

 

  • Understand European MDD and ideally MDR

  • Previous regulatory experience within the medical device industry

  • Knowledge of relevant GMP & Quality systems standard, ideally within FDA, ISO 13485

  • Experience of creating regulatory documents compliant with FDA, MDR and 93/42/EEC

 

The successful Regulatory Affairs Specialist will be offered the opportunity to join an Organisation that are having an extremely successful period in the industry, and you will drive improvement across the facility. Therefore, if you are a Regulatory Affairs Specialist that is looking for a dynamic, fast-paced environment, who would thrive in an organisation that has a genuine appetite for Regulatory compliance please get in touch.