A leading international medical device organisation specialising in the commercialisation and manufacture of innovative products are seeking to appoint a Global NPI & Regulatory Affairs Engineer to join their expanding R&D hub in the West of Ireland.
Reporting to the Quality Director, the Global NPI and Regulatory Engineer will focus on three main areas, namely, Regulatory Compliance, Central Process and NPD Stage Gate Process and will be required to:
- Be custodian of new product data, migrating these to the Materials Requirement Planning System, mitigating financial or service risks to the company
- Ensure product portfolio regulatory compliance developing technical files for CE Marked products
- Ensure FDA audit conformance and Proposition 65 Warning implementation
- Participate in traceability projects and implement the company's Unique Device Identifier (UDI) initiative
The successful candidate is required to have the following expertise and experience:
- A qualification to degree level in Engineering or Quality
- At least 2 years' NPI experience
- An ability to communicate well and regularly with members of cross-functional or multidisciplinary teams
- Strong data analytical skills
- Proven project management skills
- A results-driven influencer with interpersonal savvy
- Proficiency with MS Office is essential, while MFG Pro or Oracle experience would be advantageous
- A willingness to travel (10%) is required
For more information on this opportunity contact Aidan Toner on +353 91782110 for a confidential discussion.