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QARA Consultant

3 months ago


Neath, Neath Port Talbot, United Kingdom Hunter Selection Limited Full time

QARA Consultant Job Opportunity

Location: Port Talbot SA12

Areas nearby: Swansea, Bridgend, Pyle, Porthcawl, Neath, Llanelli, Ammanford, Cross Hands

Salary: Negotiable and dependent on experience

Company Benefits:

  • Standardised pension
  • Free parking
  • Life Insurance
  • 25 days of annual holiday
  • Sick pay package
  • Hybrid working model

We have partnered with a growing medical device company seeking a QARA Consultant. This role offers the chance to collaborate with various medical device firms, from small-scale to large corporations. It suits a seasoned professional familiar with regulatory affairs in the medical device sector, handling tasks like clinical evaluations and risk management.

Role & Responsibilities:

  • Ensure compliance with industry regulations and client standards
  • Design and execute quality assurance processes
  • Perform audits to assess adherence to quality standards
  • Offer guidance on regulatory requirements
  • Work with teams to uphold product quality and safety
  • Manage regulatory submissions
  • Stay informed on evolving regulatory requirements
  • Assist in resolving compliance issues

Key Requirements:

  • Relevant degree in medical engineering or life sciences, plus lead auditor certification
  • Prior experience in the medical device sector is a must
  • Proven track record in clinical evaluations, technical file creation, and risk management
  • Experience with ISO13485 standards
  • Background in regulatory affairs and quality assurance
  • Preferably 5+ years of experience

If you are intrigued by this opportunity, send your CV to us. Do not miss out on a chance to join a dynamic team in the medical device industry.

About Us:

Hunter Selection Limited is a renowned recruitment consultancy specializing in permanent and contract roles within multiple sectors like Engineering & Manufacturing, IT & Digital, Science & Technology, and Service & Sales.

Please be aware that we can only respond to applicants whose qualifications align with the job requirements due to the high volume of applications we receive. This advertisement does not discriminate against any protected characteristics under the Equality Act 2010.

As per the Conduct Regulations 2003, we act as an Employment Agency for permanent vacancies and an Employment Business for temporary/contract positions.