Job Description
Our client is currently looking for a Regulatory Affairs Specialist for a Permanent position in the facility in Galway. The Regulatory Affairs Specialist will be 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 specifications or quality systems.
•Understands and proactively follow through on the Environmental Management Procedures that have been identified as relevant to the position.
•Understand and implement the Product Lifecycle processes sustaining activities.
•Participates in Regulatory Body audits such as FDA, DEKRA, HPRA.
Qualifications:
•Level 8 Degree in Science/Engineering discipline or equivalent with a minimum of 5 years’ experience.
•Good interpersonal, communication and teamwork skills essential.
•Previous experience within Regulatory Affairs would be an advantage.
For further information on this Regulatory Affairs Specialist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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