1 to 4 of 4 Market Surveillance Jobs in the South East

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-Market Surveillance: Conduct post-market surveillance 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 »

compliant to EU/UK MDR (Medical Device Regulation) Identifying, interpreting, evaluating and incorporating information from various sources appropriate to the device Analysing post-market surveillance data and risk management data to ensure consistency and alignment in CER (Comparative Effectiveness Research) Evaluating clinical evidence from published literature, post … market surveillance, 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 »

responsible to maintain the effectiveness of the Quality Management System, including, but not limited to, Document Control, CAPA, Vigilance, Risk Management, Internal Audit, Post-Market Surveillance, 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 »