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Regulatory Affairs Consultant
2 months ago
Regulatory Affairs 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.
24196/617
To apply please email your CV / resume to
If you are interested in this position please click 'apply'.
Hunter Selection Limited is a recruitment consultancy with offices UK wide, specialising in permanent & contract roles within Engineering & Manufacturing, IT & Digital, Science & Technology and Service & Sales sectors.
Please note as we receive a high level of applications we can only respond to applicants whose skills & qualifications are suitable for this position. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010.
For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
