Customer Quality member responsible for completing Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions.
- 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 legal teams
- Partner 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
- 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 worldwide 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.
- Requires organizational and critical thinking skills.
- Demonstrates ability to respond to the urgent needs of the team, with a proven track record of meeting deadline.
- Knowledge of basic medical terminology.
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