Purpose: Responsible for Regulatory Affairs support of the sustaining activities required to maintain products’ legal status, submissions and regulatory compliance.
- 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.
- 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