Our client is a leading medical device company and they are currently looking for a Post Market Compliance Specialist on an initial 11 or 12 month contract.
Responsibilities: (to include but not limited to)
Functionally reports into the Regulatory Manager. You will have the responsibility for ensuring a smooth and efficient Post Market Surveillance process
·Manage daily complaint handling and analysis.
·Liaise and communicate with relevant authorities.
·Analyse high risk complains to determine if they are re-portable or not.
·Hold weekly meetings with stakeholders.
·Liaise with investigations sites etc.
·Co-ordinate the reporting of all reportable Incidents:
·Responsible for training field engineers and other relevant staff in relation to company’s regulatory obligations.
·review complaint investigation reports.
The ideal candidate will have a Bachelors or Associates Degree in a related field or have 3-5 years of in-depth experience in Post Market Compliance activities and may have worked in a similar position or responsible position with quality and customer focus.
·Basic knowledge of Medical Device Directive 93/42/EC & ISO-13485 standard.
·Excellent analytical and communication skills.
·Excel and Word skills.
·Agile in terms of priorities etc.
·Strong team skills.
APPLICANTS SHOULD HAVE FULL WORKING STATUS FOR IRELAND WITH RELEVANT EXPERIENCE AND FLUENT ENGLISH
|Job Category||Medical, Medical Devices, Technical and Engineering|