Reg Affairs Specialist

7 days ago

Galway, Galway, Ireland Life Science Recruitment Ltd Full time
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 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.

To apply for more info call me on or email Benefits: Hybrid working

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