Role: Regulatory Affairs Engineer
Location: Parkmore, Galway (Hybrid working)
Benefits: Top salary
Company:
My client are a growing Medical Device company who have recently moved into a high tech new site in Parkmore. They have developed an innovative new technology to improve the performance of Vascular stents.
Role:
Reporting to the Senior Regulatory Affairs Manager, as a Regulatory Affairs Specialist you will play a key a key role in the implementation of post-market activities within Veryan. This is a fantastic opportunity, which will allow you to gain international experience while working as part of a supportive, collaborative team in the state-of-the-art facility in Galway.
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 identified by Veryan.
* 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 by Veryan Medical for regulatory compliance in all territories for post-market activities.
* Other RA activities, identified on the job, as required.
Role: Regulatory Affairs Engineer
Location: Parkmore, Galway (Hybrid working)
Benefits: Top salary
Company:
My client are a growing Medical Device company who have recently moved into a high tech new site in Parkmore. They have developed an innovative new technology to improve the performance of Vascular stents.
Role:
Reporting to the Senior Regulatory Affairs Manager, as a Regulatory Affairs Specialist you will play a key a key role in the implementation of post-market activities within Veryan. This is a fantastic opportunity, which will allow you to gain international experience while working as part of a supportive, collaborative team in the state-of-the-art facility in Galway.
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 identified by Veryan.
* 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 by Veryan Medical 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.
* A minimum of 3 years’ relevant experience in the medical device or pharmaceutical industry is required.
* Experience in Regulatory Affairs/Quality Assurance is preferred.
To apply for more info call me on 087 0612325 or email Thomas.gallagher@lifescience.ie
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