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Senior QA & Regulatory Specialist - Medical Devices

Scienceabode

Corsham

On-site

GBP 37,000 - 43,000

Full time

30+ days ago

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Job summary

A medical device company in Corsham is seeking a Quality Assurance and Regulatory Affairs Specialist to ensure adherence to quality and regulatory standards. You will implement quality systems, monitor key performance indicators, and assist in regulatory submissions. The ideal candidate will have at least 4 years of relevant experience and a bachelor's degree. Competitive salary and benefits are offered.

Benefits

25 days holiday plus bank holidays
Company pension scheme

Qualifications

  • 4+ years' experience in Quality Assurance or Regulatory Affairs in the medical device industry.
  • Strong knowledge of EU MDR and IVDR regulations.

Responsibilities

  • Implement and improve the Quality Management System.
  • Monitor quality performance and KPIs.
  • Support regulatory submissions and product registrations.

Skills

Quality Assurance
Regulatory Affairs
Analytical skills
Communication skills
Problem-solving

Education

Bachelor's degree in Biomedical Engineering or Life Sciences
Job description
A medical device company in Corsham is seeking a Quality Assurance and Regulatory Affairs Specialist to ensure adherence to quality and regulatory standards. You will implement quality systems, monitor key performance indicators, and assist in regulatory submissions. The ideal candidate will have at least 4 years of relevant experience and a bachelor's degree. Competitive salary and benefits are offered.
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