Quality & Regulatory Associate

About the jobFisher & Paykel Healthcare is a major employer in the medical device industry, with a global reach. Our company operates in 40 countries and distributing products to over 125 countries worldwide. We are a well-established and innovative company with a history of strong and continuous growth.About the RoleThe following qualifications are expected from the candidate who should have excellent interpersonal skills, problem-solving skills, planning and project management skills, an analytical mindset, and who should be detail oriented, self-motivated and proactive. Engineering degree (biomedical or electronics engineering preferred)1-2 years’ experience in quality and/or regulatory managementVery good working knowledge of MS OfficeExcellent command of English Strong organizational and communication skills.Responsibilities and DutiesThis position will be responsible for the following tasks:Regulatory Requirements:Management of regulatory and statutory requirements (ÜTS…etc)Keep informed of any changes in relevant regulations and ensure Fisher & Paykel Healthcare Turkey compliance together with the support of the external regulatory consultantLiaise with Turkish Ministry of Health and/or other national authorities for approvals and compliancePrepare and maintain regulatory documentation and ensure timely submissionsQuality Requirements:Management and monitoring of internal QMS requirementsGather data and produce statistical reports on Quality related metricsCoordinate corrective and preventive actions (CAPA), including complaint handling and field actions.Identify, document and take preventative and corrective actions in relation to issues of non-compliancePromote the quality culture across the businessCross Functional Collaboration:Work with global and regional regulatory and quality teams to align local processesParticipate in monthly regulatory and quality calls Assist colleagues with general office tasks - support local finance, sales, or logistics functions when neededHelp maintain a smooth-running office environment, including vendor coordination and basic IT troubleshooting