Our client, a leading Medical Device organisation in Clonmel, are looking to recruit a Regulatory Affaris Specialist on a permanent basis.
- Support strategies for regulatory approval of medical devices.
- Coordinate submission activities for a variety of device regulatory approvals including: US premarket approvals and supplements, international design dossiers, post-approval support through change management review and international regulatory approval activities.
- Serve as internal consultant on regulatory issues such as review of proposed device and manufacturing changes.
- Develop and deliver presentations to management at Boston Scientific Clonmel - topics may include submission strategies, compliance issues or highlight updates to regulations as well as provide guidance on new regulatory requirements.
- Communicate submission requirements to internal customers such as product development teams. Work with new product engineering and project teams to provide guidance on potential regulatory requirements in a number of product classifications.
- Research regulatory requirements for assigned geographies. Monitor emerging trends and integrate new requirements into department procedures and toolkits.
- Participate in training and mentoring of staff.
- Bachelor?s Degree in Science or a related discipline
- 2+ years? experience within a similar role
For further information on this RA Specialist role in Clonmelplease contact Nicola O?Connell on 091730022 / firstname.lastname@example.org
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