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Global NPI & Regulatory Affairs Engineer

Job Title: Global NPI & Regulatory Affairs Engineer
Contract Type: Permanent
Location: Galway
Industry:
REF: 93178
Job Published: 3 months ago

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 086 8395533

Global NPI & Regulatory Affairs Engineer
Our client, a manufacturing company in Galway are currently looking to recruit a Global NPI & Regulatory Affairs Engineer for their site.

Key Responsibilities of the Role
Central Process Team
  • Member of the Central Process team responsible for product set ups on Principal entity MRP system, manage the changes associated with set ups to ensure consistency for both manufacturing and selling sites.
  • Develop a comprehensive audit function to ensure information loading and exceptions are highly visible before any flows become live globally, preventing potential financial and service risks.

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, ensuring sites are compliant at all times for this process, to ensure no impact to placement of lenses for sale in the US Marketplace.
  • Ensure the organization manages changes in regional or state laws such as Prop 65 California, and UDI (Unique Device Indicator) requirements for Class 1 medical devices under FDA.

NPD (New Product Development) Stage Gate Process
  • Represent Operations on the development, implementation and operation of the New Product Stage Gate Process, and assume ownership of the NPI Stage of the process once operational.
  • Co-ordinate the global NPI function, executing actions plans to support business goals and drive efficiencies throughout the use of the IRIS System (New Product Management System)
  • Manage new packaging development ensuring relevant regulatory, trade mark and brand compliance is maintained on all product packaging.
  • Participate as key member of project team for any new generation product launches, from feasibility review through to commercial sale of product.

Key Requirements (Education and Experience)
  • Degree in an Engineering/Quality discipline
  • Min 5 years’ experience in New Product Introduction environment
  • Good communicator and able share information to all levels of the organisation
  • Influence decisions and actions
  • Strong analytical skills for auditing and data analysis is required
  • Proficient in Microsoft programs such as Access Databases, Excel, PowerPoint and Word.
  • Proven project management skills
  • Interpersonal savvy
  • Drive for results
Desirable
  • Experience in IT MRP systems such as MFG Pro or Oracle

For further information on this Global NPI & Regulatory Affairs Engineer role in Galway please contact Bimi Felix on 086 8395533 / bimi@hero.ie
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