Reg Affairs Specialist
2 weeks ago
I'm delighted to be working for one of our excellent clients on a Mat Leave (6-9 months) fixed term contract role. This role is 2 days a week on site in their state of the art facility in Galway, Parkmore Business Park. You will play a key role in the implementation of post-market activities.
Job Requirements
Principal Responsibilities
- Responsible for the implementation of PMS activities identified under as defined in relevant Quality System procedures and Work Instructions.
- Support and lead Regulatory Post Market System improvements.
- Participate in the implementation of Field Safety Corrective Action plan and associated activities.
- Manage RA activities for Design Changes and Supplier-related changes including reporting assessment and generation of regulatory submissions.
- Provide RA Support to relevant Design Teams for Key Projects.
- Provide support to other RA Specialists in achieving success for the team.
- Support Gap Assessment process and associated process improvements.
- Provide support in onboarding new territories and re-registration activities in approved territories.
- Support of PMA Annual Periodic Reporting system and approval of annual documentation for submission to FDA.
- Review and approval of RA QMS procedures and work instructions and ensure activities are performed in line with these.
- Implement Technical File for updates arising from changes.
- Identify and awareness of new regulation requirements or changes required to be considered for regulatory compliance in all territories for post-market activities.
- Other RA activities, identified on the job, as required.
Education & Training
- Bachelor's degree (Level 8 NFQ) or relevant Diploma in Engineering/Science or related discipline.
- Where Degree / Diploma is from another area, relevant experience may be accepted.
Experience & Skills
- A minimum of five years' relevent experience in the medical device or pharmaceutical industry is required.
- Experience in Regulatory Affairs/Quality Assurance is preferred.
- Excellent attention to detail, communication skills, organisational skills, team working skills and problem solving skills is required.
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