Our client is a global medical device healthcare solutions company who are committed to improving lives through medical technologies, services, and solutions. They operate across 350 facilities in 150 countries, with an innovative portfolio of over 46,000 patents. They are currently looking for an MDR Vigilance Specialist.
This exciting contract role where the successful candidate will be part of a team of specialists within an MDR Vigilance Group in Galway.
Key Responsibilities would include:
- Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
- Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
- Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardisation and internalization as well as to ensure the accuracy and quality of safety summaries.
- Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
In order to be considered for this exciting daily rate MDR Vigilance Specialist role, specific requirements for the successful candidate would include:
- Qualified to Minimum of a Bachelor's degree (Level 8 NFQ) in Engineering/Science or a related discipline.
- 3+ years' experience within the Medical Device sector.
- Experience in biomedical materials, processing knowledge and medical device design procedures.
What's on offer:
- Exciting long-term daily rate contract role within a leading global healthcare solutions company.
- Opportunity to work within a global leader giving you access to build your portfolio within the medical device industry.
- Potential for a long term opportunity within the organisation.
To discover more about this opportunity, apply now or contact Laura Gallagher at HRM on +353 91 782 113 for a confidential discussion.