Regulatory Affairs Engineer
We are seeking a highly skilled Regulatory Affairs Engineer to play a key role in the implementation of post-market activities within our organization.
Job Description:
* 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 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 identified by our 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 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 by our organization for regulatory compliance in all territories for post-market activities.
* Other RA activities, identified on the job, as required.
Required Skills and Qualifications:
* Bachelor's 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.
Benefits:
* Hybrid working
About Us:
We are a growing Medical Device company who have recently moved into a high tech new site. We have developed an innovative new technology to improve the performance of Vascular stents.