Quality & Regulatory Associate

Fisher & Paykel Healthcare; Yenimahalle; On-site; TRY 150,000 - 300,000; Full time

Job summary

A leading medical device company in Turkey seeks a qualified candidate for regulatory and quality management. Responsibilities include ensuring compliance with regulations, managing QMS, and collaborating with global teams. Required skills include excellent interpersonal and problem-solving abilities, and a degree in engineering. Experience in quality/regulatory management is preferred. The role requires a strong command of English and proficiency in MS Office.

Qualifications

• 1-2 years’ experience in quality and/or regulatory management.
• Very good working knowledge of MS Office.
• Excellent command of English.

Responsibilities

• Manage regulatory and statutory requirements.
• Ensure compliance with Turkish Ministry of Health.
• Prepare and maintain regulatory documentation.
• Monitor internal QMS requirements.
• Coordinate corrective and preventive actions (CAPA).
• Promote quality culture across the business.

Skills

Interpersonal skills

Problem-solving skills

Planning and project management skills

Analytical mindset

Detail-oriented

Self-motivated

Proactive

Education

Engineering degree (biomedical or electronics preferred)

Tools

MS Office

Job description

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 candidate should have excellent interpersonal skills, problem-solving skills, planning and project management skills, an analytical mindset, and 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