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RA Specialist

Hempsted
2 days ago
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Selexa Life Sciences are delighted to partner with a leading Medical Device manufacturer in the search for a Regulatory Affairs Specialist to join their high-performing RA team based onsite in Cheltenham.

Reporting into the Group Regulatory & Quality Director, as an RA Specialist you will be responsible for the assurance of our client's device adherence and compliance to industry standards and regulations.

Role Responsibilities:

As an RA Specialist, you will be responsible for:

  • Working closely with the Group RA Manager to manage Notified Body requests, Competent Authorities and country-specific regulatory agencies globally

  • Support internal and external auditing process to ensure proess confirmity and ensure our client's product range adheres to regulations

  • Responsible for Technical File update and maintenance in line with specific requirements

  • Work closely with RA Manager for Technical Documentation, QMS and adherence to regulatory guidlines

  • Ensure consistent and regular updates for device compliance, clinical evaluation and relevant/required follow up

  • A strong working knowledge of QMS, Risk Management and global device knowledge, as well as CAPA management experience

    Skills and Qualifications:

  • Degree in Biomedical Engineering, Life Sciences or Engineering discipline

  • 2-5 years QARA knowledge within medical device sector – ISO13485

  • Knowledge of Clinical Evaluations, Tech Files, MDR 2017, and Post Market working knowledge

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