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July 22 2018

    Job details


Job description:

   » Job ID.:15367673
   » Employer ID.:RI/46790
   » Published:12-JUL-2018
   » income:NEGOTIABLE
   » Job location:NAVAN, MEATH
   » Employment Type:PERMANENT


The Post Market Compliance Specialist (PMS)is responsible for ensuring the company is compliant with European Medical Device Directive and ISO:13485 with regards to Post Market Vigilance.

PMS The main responsibilities are:
Functionally reports into the Regulatory Manager. You will have the responsibility for ensuring a smooth and efficient Post Market Surveillance process. The Post Market Compliance Specialist is responsible for the following main tasks:
   » Liaison for all communications with Competent Authorities for Post Market Vigilance.
   » Conduct everyday complaint handling activities to include assessment of all identified potentially reportable complaints.
   » Determine whether high risk complaints are reportable or non-reportable to the significant Competent Authorities.
   » Hold weekly meetings with potentially reportable complaints team (product engineers, clinical, regulatory teams in USA) to gain consensus for reportable complaints to European, MEATI authorities and FDA where appropriate.
   » contact with Service Centres and investigation sites to ensure accurate and complete investigation and repair data is recorded.
   » Conduct follow up for additional information to ensure complaints are documented fully and completely.
   » Monitor complaints/product deficiencies, to ensure they are categorised appropriately to high/low risk.
   » Notifying, updating and answering queries for all Competent Authorities and significant Management teams of the progress of the Field Action.
   » Such other tasks or projects as may be determined from time to time. For more information or to apply Contact Us by Tina Egan on 09064 78104.
Please Note: Collins McNicholas will not forward your details to any company without your prior approval.
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Job Category: Customer Service [ View All Customer Service Jobs ]
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Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Meath
Company Type Employer
Post Date: 07/12/2018 / Viewed 19 times
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