* 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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The Life Science Specialists