Collins McNicholas

RA Admin/Officer responsibilities

  • Change Control System / Document Control-Manage / Track change control, storage, release and distribution of all approved documents
  • Liaise with all departments to ensure continued corporate compliance
  • Support Management review and Management of external 3rd party audits.
  • Provide Regulatory support to new product introduction and product transfers teams.
  • Ensures the biocompatibility requirements of the product are adequately addressed.
  • Ensures the clinical requirements of the product are adequately addressed.
  • Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
  • Support all Product design and process changes requiring regulatory support
  • Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as needed or collaborates with their assigned regulatory specialists on same.
  • Review and approve all related change orders and perform the necessary regulatory assessments, working with a larger regulatory team to determine pre-approval requirements.
  • Provide support to solve and reply to any regulatory query.
  • Help to manage and maintain all RA documentation including Technical Master File

RA Admin/Officer experience:        

  • Previous regulatory experience in a Medical Device manufacturing Facility
  • Strong computer skills – Change control management; design, process and system.
  • Familiarity with ISO quality systems (MDD 93/42/EEC/MDR –  ISO13485 – 21 CFR 820)
  • Good customer relation skills
  • Risk Management including FMEA generation

For more information or to apply please contact Tina Egan on tina.egan@collinsmcnicholas.ie 09064 78104.

Please Note: Collins McNicholas will not forward your details to any company without your prior approval.

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To see a full list of jobs available across Ireland please visit our website at www.collinsmcnicholas.ie

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