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REGULATORY AFFAIRS ASSOCIATE

 

Job Reference Number

14613213

Client ID:

RI/JD250589

Posted On:

Jul 17 2012

Location:

TIPPERARY

Job Type:

Permanent

Salary:

NEGOTIABLE

Our client, alarge health care company is looking for a Regulatory Affairs Associate to join their team on a permanent basis. This position is located in the Munster region.

Key responsibilities:

  • Strategy development for regulatory approval of medical devices
  • Coordinate submission for regulatory approvals; clinical trials, pre-market approval
  • Consult internally on issues such as recalls, advertising or review of device changes
  • Develop and deliver presentations to regulatory agencies,
  • Research regulatory requirements for assigned geographies.
  • Participate in training and mentoring of staff
  • Coordinate IFU development activities
  • Participate in department systems development initiatives


Key Requirements :

  • A minimum of 6+ years experience working in regulatory affairs in a necessity
  • Bachelors degree
  • Advanced degree is preferred but not necessary
  • A solid understanding of business concepts, procedures and practices are key requirements.
  • Problem solving ability
  • Strong leadership is a must
  • The ideal candidate will be extremely Organised and attention to detail are vital for this position
  • Decision maker skills are necessary


This opportunity offers candidates the chance to work in a very dynamic company. If you are interested and feel you have the desired qualification apply to Jennifer Dawson at Sigmar Recruitment. Jennifer can be contacted at 01-4744636 in relation to the role.