Qureos Mentor

Fisher & Paykel Healthcare

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 About the job
 
 
 
 
 Fisher &amp; 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.
 
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 Engineering degree (biomedical or electronics engineering preferred)
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 1-2 years&rsquo; experience in quality and/or regulatory management
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 Very good working knowledge of MS Office
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 Excellent command of English
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 Strong organizational and communication skills.
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 Responsibilities and Duties
 
 
 
 
 
 
 This position will be responsible for the following tasks:
 
 
 
 
 
 
 Regulatory Requirements:
 
 
 
 
 
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 Management of regulatory and statutory requirements (&Uuml;TS&hellip;etc)
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 Keep informed of any changes in relevant regulations and ensure Fisher &amp; Paykel Healthcare Turkey compliance together with the support of the external regulatory consultant
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 Liaise with Turkish Ministry of Health and/or other national authorities for approvals and compliance
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 Prepare and maintain regulatory documentation and ensure timely submissions
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 Quality Requirements
 
 :Management and monitoring of internal QMS requirements
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 Gather data and produce statistical reports on Quality related metrics
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 Coordinate corrective and preventive actions (CAPA), including complaint handling and field actions.
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 Identify, document and take preventative and corrective actions in relation to issues of non-compliance
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 Promote the quality culture across the business
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 Cross Functional Collaboration
 
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 Work with global and regional regulatory and quality teams to align local processes
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 Participate in monthly regulatory and quality calls
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 Assist colleagues with general office tasks - support local finance, sales, or logistics functions when needed
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 Help maintain a smooth-running office environment, including vendor coordination and basic IT troubleshooting
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Quality & Regulatory Associate

Join Fisher & Paykel Healthcare and explore 1   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Fisher & Paykel Healthcare

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Quality & Regulatory Associate