J&J Family of Companies Director - Implementation & Data Mgmt (EU MDR) in Ireland
Job title – Director, Implementation & Data Management
Location: EMEA and or USA
The new European Medical Device Regulation (EU MDR) ensures high standards of quality and safety for medical devices that are being produced in Europe or being supplied to the European market. EU MDR is establishing a robust, transparent, predictable and sustainable regulatory framework to ensure a high level of health and safety whilst supporting innovation.
Within Medical Devices, it is the largest regulatory program undertaken at J&J to-date, driving substantial changes which pose both opportunities and challenges for our customers and patients, as well as for our internal businesses and associated functions.
The EUDAMED & Data Implementation Lead is a high-profile, leadership role, tasked with the ongoing development of the EUDAMED Implementation strategy and its execution throughout the full EU MDR program horizon.
In addition, the role serves as the Business Product Owner for Data Management, ensuring that the data needs of EU MDR partners are surfaced, defined and delivered via the ongoing evolution of the Data Management solution. As the EUDAMED modules are now coming online and are a foundational requirement for compliance with the new regulation, this role will become increasingly visible across not just the program, but amongst partners and the executive EU MDR Steerco.
Coupled with the servicing of significant data needs, via Data Management - such as UDI, Vigilance, Economic Operator Verification checks etc - the role is the go-to point for all data and EUDAMED aspects of the program in fulfilling our EU MDR obligations.
Core Responsibilities – EUDAMED Implementation Readiness
Lead the Implementation community to deliver key readiness achievements in line with planned go-live and/or participation dates of EUDAMED modules
Support the creation of the long-term strategy @ J&J for EUDAMED & EUDAMED similar databases
Ensure the implementation and maintenance of a robust Quality Plan which supports all Med Device businesses in their EU MDR audits, including surveillance audits
Ensure the effective and continued development of the coordinated Project Plan for EUDAMED. This is critical for ensuring overall business readiness and participation
Design and deliver Business Simulation Testing which replicates the planned live environment and compliance landscape we need to successfully execute in
Engage in relevant Steerco meetings, Risk and Issues reviews, Deep Dives, and Executive forums as the need arises
Core Responsibilities – Data Management Business Product Owner
Navigate a sophisticated partner landscape; driving alignment on scope, requirements and priorities with various business and IT partners; facilitating swift decision making; and ensuring clear communication between leadership and execution teams
Handling critical relationships within and across JJ Technology who deliver the technical solution and expertise to support the translation of requirements into tangible solutions
Developing and implementing project execution plans; identifying and managing interdependencies across the MDR workstreams and IT Capabilities for emerging regulatory initiatives as they relate to MDR
Eliciting and delivering effective solutions for sophisticated data needs and incorporating long term strategic foresight in data management use, in service of EUDAMED and MDR needs
Ensure a robust data governance model is implemented – demonstrating existing practices and principles implemented within Med Device
Navigate partner expectations and needs effectively in terms of feasible outcomes/expectations
This is an outstanding opportunity and a highly visible role, operating under a level of autonomy and self-direction but which requires a keen understanding of Medical Devices, our technology landscape and the EU MDR itself, with the ability to engage and affect outcomes successfully, by adapting and applying leadership, program management and risk mitigation skills.
Experience, skills & proficiencies required:
Ability to operate at senior leadership level within the organization and adept at engaging individuals and organizations across multiple levels.
Positive, resilient, and confident leader
Making the sophisticated simple and translating strategy into strong execution efforts
Knowledge of Structured Methodologies such as FPX
Ability to build & lead cross-function teams (without any direct line reporting)
Formulate recommendations that drive sound decisions and delivers results
Is not afraid to operate in spaces of ambiguity and to craft strategy and outcomes in an autonomous, but pressurized environment
Excellent proficiency in partner relationship management and networking, maintaining multiple conversations across a varied network of partners
Preferably someone with an understanding of EU DMR, our data technology landscape, the complexity of our business models and compliance obligations
A proven track record in managing across the depth and breadth of the organization in the context of a large-scale program
Proven ability to ingest and distil large volumes of information and data and translate into relatable context and content for a varied audience
Has a broad knowledge of the J&J Med Device sector and key Franchises i.e. Ethicon, Depuy Synthes, CSS
Prior experience of compliance programs i.e. Global UDI
An ability to translate tactical compliance requirements into relatable implications and subsequent solutions for our business is required
Closing date – Tuesday 2nd March 2021
What type of mark will YOU make?
By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world’s healthiest workforce you can strengthen your body as well and your mind. When you work with us you can touch over a Billion lives worldwide every day. And when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together. And that changes everything.
What’s in it for YOU?
It’s vital to us that you feel you can bring your whole self to work; at J&J we provide an environment for you to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive wage and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life. Examples of this include: online Digital GP, private healthcare, Retail Vouchers, Discounted & Subsidised Gym memberships and you can get to support community projects as part of our global Corporate Social Responsibility programme.
What we’re about:
We are passionate about our work and play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. We share a kind of DNA where we’re each
Committed to caring
Responsible to our communities
Ready to apply our knowledge and know-how
Unique in our background and experiences
The drivers of our own success
Passionate about doing what’s right
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified individuals will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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Johnson & Johnson (Ireland) Limited (8180)
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