NegotiablePort Talbot, Neath Port Talbot
QARA Consultant
QARA Consultant
Port Talbot SA12
Commutable from Swansea, Port Talbot, Bridgend, Pyle, Porthcawl, Neath, Llanelli, Ammanford, Cross Hands
Salary – Negotiable and dependent on experience
Benefits:-
Standardised pension
Free parking
Life Insurance
25 days of annual holiday
Sick pay package
Hybrid working model
We are exclusively partnered with an expanding medical device business who are looking to acquire a QARA Consultant. This role will provide you with the opportunity to work with a wide variety of medical device businesses ranging from family businesses to multinationals. This role would be well suited to an experienced candidate with experience working in the medical device sector within the field of regulatory affairs completing tasks such as clinical evaluations, risk management.
Role & Responsibilities:
Ensure compliance with industry regulations and standards in line with client requirements.
Develop and implement quality assurance processes
Conduct audits (stage 1 and 2) to assess adherence to quality standards
Provide guidance on regulatory requirements
Collaborate with teams to maintain product quality and safety
Navigate regulatory submissions for products
Stay updated on evolving regulatory requirements
Assist in resolving compliance issues and implementing corrective actions
Knowledge, Skills & Experience:
A degree in medical engineering or a life sciences subject will be beneficial, alongside a lead auditor qualification.
Experience working in the medical device sector is essential.
Proven experience in managing clinical evaluations, technical file creation and risk management.
Proven experience of working to ISO13485.
Working in a regulatory affairs and quality assurance capacity will be required for this position.
The successful candidate will ideally have 5+ years of experience.
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