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|Date Posted||May 25, 2018|
Accountancy and Finance
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