EY Technology Consulting Digital Manufacturing Medical 

Ireland 

918149095

What we offer and how we will support your Career progression

• Success as defined by you: We’ll provide the tools and flexibility, so you can make a meaningful impact, your way.
• Continuous learning: personalised career development including coaching, experiences and formal learning so you’ll develop the mindset and skills you’ll need to thrive in the future. Transformative leadership, we will give you the insights, coaching and confidence to be the leader the world needs.
• Career progression: When you join EY, you will be supported to ensure that you are enhancing your skills from day one. As you grow and develop here, you’ll discover opportunities to help customise your career journey, so that it’s as unique as you are.
• Benefits: We offer a competitive remuneration package where you’ll be rewarded for your individual and team performance. Our comprehensive Total Rewards package includes support for flexible working and career development, and with FlexEY you can select benefits that suit your needs, with a wide range of discounts, offers and promotions. Your experience in EY will also include:
• Free enrolment in EY’s Tech MBA Programme accredited by Hult International Business School
• Discounted health insurance
• Pension
• The purchase of additional annual leave
• Hybrid Working model

Your key responsibilities

• The role requires experience of Notified Body decision making who can both support the new Director and also the current senior medical devices management team who are deciding on activities like medical submissions, client management etc.
• Plan and manage audits and product technical file reviews in conjunction with client service representatives as well as resources from other regions.
• Liaise with auditors and product technical file reviewers in relation to site issues, standards, product and regulatory issues. Provide input into technical review of audit packages and product technical file review.
• Support communications with associated accreditation bodies including external audit preparation, corrective actions, invoicing and any other associated requirements. Review and implement accreditation updates /bulletins.
• Attend meetings and conferences as required promoting NSAI at national and international level. Co-operate and work with the Business Development and Marketing functions within NSAI, in order to maximise the marketing potential of the NSAI’s Medical Device operations and the maintenance of Client Relations.

Skills and attributes for success

• Experience of working with a notified body like NSAI, TUV, BSI, Dekra etc is essential . The role requires experience of Notified Body decision making who can both support the new Director and also the current senior medical devices management team who are deciding on activities like medical submissions, client management etc.
• Experience of around 8-15 years working with Medical devices manufacturers
• Good Experience and understanding of the new EU MDR 2017/745 and IVDR 2017/746 Stage 1 audits
• Good understanding of MDSAP standards
• Any experience of working with CE certification for devices is also desirable