london, south east england, United Kingdom Hybrid / WFH Options
Barrington James
Junior Consultant with 2-5 years of experience in Regulatory Affairs. This role requires hands-on involvement with the management of technical files, post-market regulatory activities, global device registration, and formulating regulatory strategies. Quality Assurance experience is an added advantage. Key Responsibilities: Regulatory Submissions: Prepare and submit regulatory … medical devices. Compliance Monitoring: Monitor and interpret regulatory requirements, ensuring that company products and practices are in compliance with relevant regulations and standards. Post-MarketSurveillance: Conduct post-marketsurveillance activities, including adverse event reporting and PMS reports. Validation Testing: Participate in the planning and execution … Assist in the preparation and maintenance of Clinical Evaluation Reports (CER). Regulatory Strategy: Support the development of regulatory strategies for new products and market entries. Stakeholder Communication: Liaise with internal and external stakeholders, including regulatory bodies, to address queries and provide regulatory guidance. Key Qualifications: 2-5 years more »
Wokingham, England, United Kingdom Hybrid / WFH Options
Intersurgical
compliant to EU/UK MDR (Medical Device Regulation) Identifying, interpreting, evaluating and incorporating information from various sources appropriate to the device Analysing post-marketsurveillance data and risk management data to ensure consistency and alignment in CER (Comparative Effectiveness Research) Evaluating clinical evidence from published literature, post … marketsurveillance, risk assessments and post-market clinical data, and be able to generate a report of these data Ensure that Clinical Evaluation Plans/Reports and databases are kept compliant and up to date Managing timelines and communication to ensure deliverables and milestones are met Assisting more »
Cardiff, Wales, United Kingdom Hybrid / WFH Options
Gyrus Medical Ltd An ATL Technology Company
and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: Corrective and Preventive Action (CAPA), Complaint, Post MarketSurveillance and Non-conformance Report (NCR). Provision of advice according to established procedures relating to CAPA, Complaint, Post MarketSurveillance … Employee Assistance Programme About ATL Technology ATL Technology is a fast-growing provider of outsourced design, development and manufacturing services to the medical device market, and its UK site is based in St Mellons, Cardiff. We believe that there is a better way to bring medical devices to marketmore »
Cardiff, South Glamorgan, Wales, United Kingdom Hybrid / WFH Options
Gyrus Medical Ltd An ATL Technology Company
and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: Corrective and Preventive Action (CAPA), Complaint, Post MarketSurveillance and Non-conformance Report (NCR). Provision of advice according to established procedures relating to CAPA, Complaint, Post MarketSurveillance … Employee Assistance Programme About ATL Technology ATL Technology is a fast-growing provider of outsourced design, development and manufacturing services to the medical device market, and its UK site is based in St Mellons, Cardiff. We believe that there is a better way to bring medical devices to marketmore »
projects and initiatives, seeing them through to completion You will focus on EMEA Transaction Reporting obligations such as SFTR & EMIR. You will monitor potential market abuse and enhance marketsurveillance and help maintain control standards You will provide scalability to cope with existing and new regulatory requirements more »
london (wembley), south east england, United Kingdom
Medicareplus International Ltd
responsible to maintain the effectiveness of the Quality Management System, including, but not limited to, Document Control, CAPA, Vigilance, Risk Management, Internal Audit, Post-MarketSurveillance, Supplier Monitoring and Assessment and Product Release activities Contribute to strategic improvement projects to improve business processes in line with the applicable more »
IVD Directive (98/79/EC). Lead strategies for a large product portfolio including supporting new registrations, authoring technical files, and post-market surveillance. A minimum of 8 years post-qualification experience in regulatory affairs in the medical device and/or pharmaceutical industry in product registration more »