Job Description
Our client a leading and rapidly expanding MedTech company now require a Senior MDR Vigilance Specialist to join their rapidly expanding team within cGMP environment that is FDA regulated. This company is based in Galway, however there is flexibility for this hire to work in hybrid model or remotely, as preferred.
This role offers have high visibility within commercial and development teams, providing value throughout the Product Life cycle through world class execution in Medical Device Reporting (MDR) and Vigilance compliance.
The successful candidate will lead preparation & submission of complaint handling regulatory reports to regulatory bodies. As Subject Matter Expert (SME) for the product complaints, this hire will take lead for Internal, External and Regulatory Body Inspections.
Additionally, this hire will lead the management of complaint handling activities within complaint reassessment & customer communication for a wide range of post marketed products.
Requirements for Senior MDR Vigilance Specialist:
- Line management of Vigilance Specialists within your group.
- Acting as a leader/team member on continuous improvement projects.
- Participation in the development/maintenance of cell operating systems.
- Collaboration with complaint handling partners on process & procedural improvements.
- Management of customer complaint queries.
- Conduct complaint trend analysis.
- Support risk management, risk analysis & health hazard analysis associated with complaint/post market surveillance reports.
- Assure that all product complaints are investigated to the appropriate level within the required timeline.
- Send customer response/mailbox responses.
Requirements for Senior MDR Vigilance Specialist:
- Bachelor's degree with a minimum of 5 years of experience in Quality role in a GMP related field within Medical device, biotechnology or pharmaceutical manufacturing.
- Working knowledge of cGMPs and other regulatory requirements governing EU MDR regulations or ISO13485 or similar regulations.
- Knowledge of EU/ FDA cGMP requirements pertaining to product complaints reporting and investigation.
- Desirable experiences: combination working experiences in product complaints handling, deviation management, CAPAs, quality compliance investigations, risk management, and cGMP audits.
- Good understanding of the manufacture of combination products and the linkage to customer complaints.
- Proven experience with Risk Management and Continuous Improvements.
- Must have good written & oral communication skills and the ability to communicate with cross functional people.
The RFT Group: Biopharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie / www.meddevicejobs.ie
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