We have a great opportunity for a Regulatory Engineer to join one of our Medical Device clients based in Lancaster. This is a fantastic opportunity for someone starting their Regulatory Engineering journey, or possibly someone from Quality looking to make the next step into Regs. Role Overview: Conducting Internal Audits to meet the requirements of ISO 9001, ISO 13485, ISO 14001, ISO 45001 and ISO 50001. Conducting technical file audits and supplier audits. Hosting customer audits and support notified body audits. Promoting ISO 9001:2015 & EN ISO 13485:2016 within a fast-paced manufacturing environment. Assist with matters of regulatory compliance. Project team support and technical file assistance. To oversee the training program activities. Collate complex data and interpret results. To deal with nonconformity, customer complaints and subsequent continuous improvements. To carry out general quality assurance and quality control activities as required. To create/update product quality control documentation and technical dossiers. Responsibilities: Responsible for working to HSER standards through the use of all Leadership in action tools. Responsible for meeting all legislative Health and Safety standards. Ensuring goods and products comply with company standards as well as international standards and regulatory requirements. Managing non-conformity investigations Reporting quality anomalies to Production, QA Team and Engineering Team. Provide support and guidance to the Quality Technician. Creating quality reports related to incoming and outgoing goods inspections. Managing customer and supplier complaints effectively to make sure that the real root cause analysis is completed and appropriate corrective actions implemented. Managing customer complaints and NC reports on time in accordance to KPI`s set by the company Managing improvement projects and reporting the progress to Quality & Regulatory Manager. Collating test data and drafting quality reports. Identifying possible areas for improvement in quality control processes. Ensuring production is not hindered by quality testing procedures. Creating/updating documentation related to the quality of products Experience Required: Internal auditing experience. Experience in hosting audits and conducting supplier audits. At least two years experience of quality systems applied in product manufacture against BS EN ISO 9001:2015, 13485:2016. Some experience of regulatory compliance for safety and medical device products (NIOSH, 93/42/EEC, FDA, ANVISA, etc). Min. 2 years experience working in a laboratory/metrology environment. Experience in promoting continuous improvement in manufacturing environment. ADZN1_UKTJ