Technology Consulting (Digital Manufacturing): Medical Devices Regulatory - Senior Manager (1482828)

Technology Consulting (Digital Manufacturing): Medical Devices Regulatory – Senior Manager

General information    
Location    Dublin
Business area    Technology Consulting – Digital Manufacturing
Contact type    Permanent / Full-time
Working model    Hybrid

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture, and technology to become the best version of you, we are counting on your unique voice and perspective to help EY become even better, too. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.
EY have a number of career opportunities available, and we are interested in meeting candidates who are looking for a new challenge, one where you can develop your range of skills significantly. Be that a move out of industry into practice, or from within practice into advisory services. We are looking for future leaders with a genuine creative vision and the confidence to make it happen. Our opportunities will allow you to apply your expertise to a variety of projects whilst offering you excellent career progression opportunities.

The team and the opportunity

You will play a key role in supporting the development and strengthen existing client relationships and help our clients, who are leaders in the Financial Services industry, navigate the complex finance issues facing their business. As part of this growing team, you will also get to help shape the innovative culture that makes EY such a great place to work.

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

Inclusion & Diversity
We hold a collective commitment to foster an environment where all differences are valued and respected, practices are equitable and everyone experiences a sense of belonging: Inclusion, diversity, and equity are part of who we are at EY. We believe that the highest-performing teams maximize the power of different perspectives and backgrounds. These teams are both diverse and inclusive and are willing to invite and learn from other perspectives. Our ability to include various viewpoints into our mindsets, behaviours and operations is fundamental to driving innovation, building strong relationships, and delivering the best solutions for our clients.
We recognise the strength that comes from having a diverse workforce and building a culture where we support all our people to achieve their potential. You’ll be embraced for who you are and empowered to use your voice to help others find theirs.
CIPD 2020 Diversity and Inclusion Winner, GreatPlaceToWork’s Top 20 UK’s Best Workplaces for Women 2020 (Super Large Category) And Times Top 50 Employers for Women 2019 & 2020.

Apply
If you are interested in the above role, please submit a CV via the EY Careers Site at: EY Career Page
To hear stories from professionals within our business around their experience, career advice and progression, and belonging and flexibility please visit us here.
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