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Quality Systems Specialist

Quality & Laboratory
Siobhán Lane
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Job Reference: JO-2007-65317_1596007009



* Submission of initial and final vigilance reports in accordance with MEDDEV 2.12-1 current revision.

* Co-ordinating timely responses to competent authorities and health ministry's regarding product performance.

* Co-ordinating responses to product performance enquiries from surgeons, patients and health care providers.

* Support litigation cases and co-ordinate the provision of performance data to site legal teams

* Partner with other manufacturing sites and design centres to obtain product performance summaries and data.

* Undertake product performance reviews using available data analysis tools to respond to enquiries.

* Escalate product performance concerns through the established processes

* Participate in product risk assessments providing input in order to evaluate patient risk as required

* Representing the site, be pro-active in shaping and influencing regulatory environment working with Healthcare Industry body groups and Forums (ABHI, Eucomed etc).

* Attend meetings with health care regulators as required.

* Perform all other work-related duties

* Continuous Improvement Focus

* Additional activities as deemed appropriate by the Complaints Manager.


* A minimum of a Bachelor's Degree is required.

* Regulatory/Quality Systems experience

* 3+ years Medical Devices Industries experience

* Broad experience and knowledge of world-wide quality system regulations (e.g. FDA 803, 820; ISO 13485, ISO 14971) with a working knowledge of international Health Authority reporting requirements

* Demonstrated proficiency conducting investigations and implementing corrective and preventive actions

* Ability to work in a cross-functional and matrix environment.

* Actively participates in cross-functional team meetings.

* Requires organizational and critical thinking skills.

* Ability to prioritize and multi task.

* Demonstrates ability to respond to the urgent needs of the team, with proven track record of meeting deadline.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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Siobhán Lane
Siobhán Lane
Talent Consultant
Quality & Laboratory
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