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SJB Technical Recruitment Ltd
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Bath, Somerset
Quality and Regulatory Affairs Manager Medical Devices
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Salary: From £40,000 to £60,000 per annum plus benefits |
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Overview
Quality and Regulatory Affairs Manager Medical Devices Bath £40k - £60k benefits flexible working Innovative medical device startup, combining additive manufacturing and digital technologies to create personalised medical devices, surgical planning software, VR and AR tools for surgeons with clinical trials due to start during 2020. Seeking a Quality Engineer /Manager and Regulatory Affairs specialist with · 5 years’ proven experience in medical device development (from design to market). · Good understanding of QMS culture in MedTech industry · Able to lead company ISO quality standards throughout clinical trials and markets expansion (FDA & MDSAP area). · Clear understanding of manufacturing process control for class 2b implantable devices and surgical instrumentation · Preferably knowledge of Additive Manufacturing process. · Ability to lead the process to certification of surgical planning software in line with IEC:62304 standards and new MDR. Responsibilities Ensure design and manufacturing activities are implemented to ISO:13485 standards QMS, technical file and certifications maintained (including devices CE marking) Application of Risk Management to Medical Devices (ISO:14971) Suppliers’ quality compliance Leading and implementing the internal and external auditing Changes recorded (CAPA resolution process) Identify FDA process accreditation requirements. Initiate the accreditation process for medical device software (IEC:62304). Maintain up to date knowledge of laws standards and regulations. Qualifications Bachelor’s degree in science, engineering 3 years’ experience in a Quality Engineering, QA or Regulatory role in medical devices Deep knowledge of ISO:13485, ISO:14971, FDA standards and certification processes Experience of supporting new product development in a quality role Able to act as the subject matter expert for new digital MedTech products Excellent PC skills, including QMS and Microsoft Office applications Organisational and problem-solving skills; Strong written communication skills: plans, procedures, work instructions and reports Self-motivated with leadership aptitude. Desirable: Software validation process IEC:62304 MDR and MDSAP knowledge Bilingual or with good knowledge of a second language Salary and benefits include £40,000 - £60,000 Pension, bonus and share options Flexible working practices - including optional part time or partial remote working This job was originally posted as www.totaljobs.com/job/89742973