Our client, a leading global medical device organisation based in North County Galway are seeking an experienced Global NPI & Regulatory Affairs Engineer to join the Quality team. This role will report directly to the Quality Director.

You will be a key member of the CPT (Central Process Team) and manage the regulatory compliance of the product portfolio within the global marketplace.

The Role

Central Process Team

• Product set ups on Principal entity MRP system and management any changes associated with set ups.
• Develop a comprehensive audit function.

Regulatory Compliance

• Maintain technical files for products that require CE Marking before being placed for sale on the EU Marketplace.
• Be accountable for FDA Impact Testing program for the company globally.

NPD (New Product Development) Stage Gate Process

• Represent Operations on the development, implementation and operation of the New Product Stage Gate Process.
• Assume ownership of the NPI Stage of the process once operational and co-ordinate the global NPI function
• Manage new packaging development ensuring relevant regulatory, trade mark and brand compliance is maintained.

The Person

You will have skills and experience in the following:

• Degree in an Engineering/Quality discipline.
• Min 2 year's experience in New Product Introduction environment.
• Proficient in Microsoft programs such as Access Databases, Excel, PowerPoint and Word.
• Experience in IT MRP systems such as MFG Pro or Oracle (desirable).
• Proven project management skills.
• Good communicator and able share information to all levels of the organisation.

For more information on this opportunity, talk to Laura Gallagher in confidence, email or call her direct line 091782113.