Quality & Regulatory Associate

About the job

Fisher & 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 Role

The 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 management
• Very good working knowledge of MS Office
• Excellent command of English
• Strong organizational and communication skills.

Responsibilities and Duties

This 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 consultant
• Liaise with Turkish Ministry of Health and/or other national authorities for approvals and compliance
• Prepare and maintain regulatory documentation and ensure timely submissions
• Quality Requirements :Management and monitoring of internal QMS requirements
• Gather data and produce statistical reports on Quality related metrics
• Coordinate 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-compliance
• Promote the quality culture across the business

Cross Functional Collaboration :

• Work with global and regional regulatory and quality teams to align local processes
• Participate in monthly regulatory and quality calls
• Assist colleagues with general office tasks - support local finance, sales, or logistics functions when needed
• Help maintain a smooth-running office environment, including vendor coordination and basic IT troubleshooting