Job Description
Role Overview: As a Regulatory Affairs Specialist, you will play a key role in implementing post-market activities within our organization.
This is an exciting opportunity to gain international experience while working as part of a supportive, collaborative team in a state-of-the-art facility.
Key Responsibilities:
* Implement PMS activities 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 plans 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 identified by the organization.
* Support 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 regulatory authorities.
* 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 by the organization for regulatory compliance in all territories for post-market activities.
Requirements:
* Bachelors degree (Level 8 NFQ) or relevant Diploma in Engineering/Science or related discipline.
* A minimum of 3 years relevant experience in the medical device or pharmaceutical industry is required.
* Experience in Regulatory Affairs/Quality Assurance is preferred.