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RA Specialist
Job Posted: 3 hours ago
Salary: £ 40,000 - 48,000 / Annum
Job Type: Permanent
Location: GL2, Hempsted, Gloucestershire
Expire in: a month
Job Description
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 knowledgeBefore You Apply
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