Regulatory Affairs ConsultantPort Talbot SA12Commutable from Swansea, Port Talbot, Bridgend, Pyle, Porthcawl, Neath, Llanelli, Ammanford, Cross Hands Salary - Negotiable and dependent on experience Benefits:-Standardised pensionFree parkingLife Insurance25 days of annual holidaySick pay packageHybrid working modelWe 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 processesConduct audits (stage 1 and 2) to assess adherence to quality standardsProvide guidance on regulatory requirementsCollaborate with teams to maintain product quality and safetyNavigate regulatory submissions for productsStay updated on evolving regulatory requirementsAssist in resolving compliance issues and implementing corrective actionsKnowledge, 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 jackl@hunterselection.co.ukIf 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.
Job Tenure: Permanent
Salary: Negotiable
Location: Port Talbot, Neath Port Talbot