SRG are working with a global biotechnology and healthcare organisation to help them find a Risk Management and Post Market Surveillance specialist to join the team.The company offer a comprehensive benefits package along with opportunity for development.The Role:Ensure Product Risk Management Processes are compliant with relevant Risk Management Regulations.Lead and/or support all Product Risk Management activities according to current proceduresCreate new and update existing Product Risk Management Documentation to ensure compliance with current proceduresCarry out Post Market Surveillance (PMS) activities for products in adherence with the required schedules to ensure regulatory complianceCreate and/or update PMS documentation in line with regulatory requirements and in accordance with the agreed PMS schedule (PMS Plan, SSP, PMS Report, PSUR)Ensure Product Risk Management & PMS Process efficiency according KPIs.Act as a Risk Management Team Representative during Third Party AuditContribute to Continuous ImprovementParticipate in regulatory inspections or certification audits as part of the Quality Systems TeamContribute to the regulatory watch process by maintaining knowledge of new or update regulatory requirements, guidance documents and industry standards relating to your related areas of responsibilityProviding support, guidance and training as needed to fellow team members in the areas of Risk Management and PMSRequirements:Degree in relevant scientific disciplineExperience in medical device/IVD/Biotech industry is essentialExperience in risk managementExperience carrying out Post Market Surveillance activities (PMS)Ability to analyse data and author reports
Job Title
Post Market Surveillance and Risk Specialist- Medical Technology