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Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist
Contract Type: Contract
Location: Limerick
REF: 82973
Job Published: over 2 years ago

Job Description

RA Specialist
Our client, a global leader in the Medical Device industry, are looking to recruit a RA Specialist for their site in Limerick.

  • Communicate directly with customers and internal company resources to complete information needed for the complaint file.
  • Monitor and facilitate product return for complaint investigation and analysis.
  • Clarification of information provided during the Intake process to provide better clarity surrounding event descriptions
  • Review labelling and literature for regulatory concerns.
  • Perform adverse event filings, including MDR and MDV reports.
  • Utilize risk management process to determine potential and actual risk related to complaint events.
  • Assist in compiling responses for additional information requests from Global Regulatory Agencies.
  • Analyze complaint information to identify similar events or failure modes.
  • Maintain compliance to regulations
  • Directly correspond with regulatory agencies with supervision.
  • Investigate related failures, design, and manufacturing history of failed devices
  • Ensure complaints are classified correctly and that all supporting data for investigations are adequately documented and attached to the complaint file.
  • Identifying product-associated problems
  • Assist in department initiatives and projects
  • Facilitate communication of complaint investigation results to sales reps/customers.
  • Provide data for product design projects and regulatory submissions
  • Assisting in the development and implementation of SOPs and systems to track and manage product-associated events
  • Approve regulatory filing decisions
  • Investigate department process non-conformances or potential non-conformances
  • Assist in the communication of product and/or component parts deficiencies to internal and external customers.
  • Identify and analyze non-routine product issues.
  • Ability to communicate and network with regulatory personnel to obtain relevant information
  • Ability to plan and conduct meetings
  • Supervised work with specific direction provided by senior staff
  • Developing working knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures pertaining to medical devices
Experience and
  • B.Sc in Engineering, Sciences or equivalent preferred
  • 0-2 years regulatory experience in the medical device industry
  • Knowledge of the Quality System Regulations (21 CFR), Medical Device Directives (MDD) and MEDDEV guidance

For further information on this RA Specialist role in Limerick please contact Nicola O?Connell on 091730022 /
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