Cache of job #14070463

Job Title

Regulatory Affairs Specialist - Perm - G

Employer

COLLINS MCNICHOLAS RECRUITMENT

Location

GALWAY

Description

Purpose: Responsible for Regulatory Affairs support of the sustaining activities required to maintain products’ legal status, submissions and regulatory compliance. Key Responsibilities: Working as part of a team responsible for Regulatory Activities with specific responsibility for transcatheter heart valves. Includes preparation and review of technical and process information for global submission activities as well as for change orders, working closely with R&D, DA and Operations groups. Provide support to the core team on all aspects of regulatory strategy for the valve product(s) including development and execution of plans. Review and approve documentation related to product release. Provide input, review and approve facility regulatory activities such as labelling. Provide updates on regulatory requirement changes, either on individual product specification or quality systems. Understands and proactively follow through on the Environmental Management Procedures that have been identified as relevant to position. Understand and implement the Product Lifecycle processes in particular sustaining activities. Participates in Regulatory Body audits such as FDA, DEKRA, HPRA. Qualifications: Level 8 HETAC qualification in Science/Engineering discipline or equivalent with minimum 5 years’ experience. Good interpersonal, communication and teamwork skills essential. Previous experience within Regulatory Affairs would be an advantage. For additional information please contact Chris O Toole. For more information on our Recruitment and HR Services, and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our consultants to discuss all the latest jobs!.

Date Added

1631 days ago

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