Pms Specialist

Collins Mcnicholas Recruitment

Navan, Meath

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 Responsibilities: 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 daily complaint handling activities to include assessment of all identified potentially reportable complaints. Determine whether high risk complaints are reportable or non-reportable to the relevant 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. Liaise 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 relevant Management teams of the progress of the Field Action. Such other duties or projects as may be determined from time to time. For more information or to apply please contact Tina Egan on tina.egan@collinsmcnicholas.ie 09064 78104. Please Note: Collins McNicholas will not forward your details to any company without your prior approval. Setting the Standards for Excellence in Recruitment. To see a full list of jobs available across Ireland please visit our website atwww.collinsmcnicholas.ie. This job originally appeared on RecruitIreland.com.

2172 days ago