RA Project Manager

Job Overview

Our expanding Life Sciences Client in Wexford, the ''Sunny South East'' of Ireland, have a requirement for an RA Project Manager to join their expanding teams. Exciting opportunity with excellent career development opportunities with this world-renowned Medical Device organization

RA Project Manager * Wexford *Permanent

What is in it for you?

  • This is great opportunity to expand your skillset and grow your career in this fast moving, dynamic and agile business.
  • Attractive salary and benefits package on offer together with a friendly, welcoming and collaborative working environment
  • Remote Working available
  • Onsite parking and canteen (remote working initially)
  • Days role, flexitime available & half day on a Friday!
  • Commutable distance from Kilkenny, Waterford, Tipperary or Wicklow.


Reporting to the Senior Manager Regulatory Affairs, you will be a key member of the RA team. You will be responsible and accountable for regulatory support, with a primary focus on UDI, for operations, product development and quality to ensure that the product is in compliance with all internal and external regulatory requirements.

Key responsibilities:

  • Regulatory Affairs Subject Matter Expert on UDI / EUDAMED / GUDID requirements globally (e.g. MDR UDI, US UDI, China UDI, EUDAMED, GUDID, etc.)
  • Implement and maintain global UDI /EUDAMED / GUDID requirements and associated procedures in accordance with the company wide UDI / EUDAMED / GUDID initiatives
  • Assist in the development and improvement of Regulatory processes and procedures and in the harmonization of processes within the Global RA Team
  • Train Regulatory Affairs & Quality System team members on UDI / EUDAMED /GUDID processes and systems
  • Reviews Engineering Change Orders, Design Change Notices and other deviations to assess impact to UDI
  • Participates in product development/line extension teams as required to ensure that the product is in compliance with all internal and external regulatory requirements
  • Provide positive example and actively promote compliance to all standards
  • Maintain a professional working relationship with internal and external customer and support staff;
  • Prepare and present project updates and technical discussions.


Requirements

  • Degree in Science or Engineering or relevant scientific discipline with experience in Regulatory Affairs and/or Quality Systems, preferably in the Medical Device or Pharmaceutical industry.
  • Proven Project Management experience
  • Good regulatory knowledge, e.g. guidelines, policies, principles and requirements of applicable product laws/standards.
  • Knowledge in CE marking according to MDR; EUDAMED attribute data & UDI requirements and implementation and labelling procedures.
  • Strong attention to detail and the ability to work effectively in a complex work environment with multiple and competing registration priorities.
  • Good planning and organizational skills.
  • High level of ownership and enthusiasm.
  • German knowledge is an advantage.

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