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Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist
Contract Type: Permanent
Location: Tipperary
REF: 83273
Job Published: over 2 years ago

Job Description

Regulatory Affairs Specialist ? Clonmel
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 /
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