Regulatory Affairs Consultant

Regulatory Affairs Consultant

Our client, a Medical Device company in the Midlands, currently has a vacancy for a Regulatory Affairs Consultant. This is fixed term contract for two to six months with immediate start.

Job Description

• Complete formal Regulatory File submittals for CE Marking in compliance with Medical Device Directives, Product Safety Files, and support for Vigilance activities for global market, against an aggressive timeline
• Construction and submittal of CE Technical Files for various products
• Update technical files and brand logo changes as required on associated products
• Submittal of vigilance reports etc as required, along with support for submittals via other sites
• Prepare and manage Field Safety Corrective Actions / Recall Files as may be applicable in the period
• Provide QA/RA Manager and the team with regular progress status report for each of the deliverables

Position Requirements

• Degree in relevant Science related discipline
• 3-5 years Regulatory experience within the Medical Device industry.
• Strong interpersonal and communication skills including oral and written reports
• Good project planning and organizational abilities

To apply please contact Gemma Reid at Morgan McKinley at 051 309650 or email your CV confidentially to greid@morganmckinley.ie