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EUDAMED Business Readiness Lead at USA - Smith & Nephew, Inc.

Posted in Information Technology 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Cordova, Tennessee

Job Description:

Job Description

Business Process Readiness (40%)

- Compare current-state business processes versus future state EUDAMED submissions obligations to identify gaps.

- Perform change management impact assessments to understand how specific stakeholder groups will be impacted.

- Identify functional interdependencies across processes, ensure end-to-end processes are integrated so that processes are efficient/effective.

- Ensure the creation and/or integration of EUDAMED related process into global policies, procedures, work instructions.

- Coordinate with site or franchise level processes owners to identify all locally impacted processes and documentation.  Track completion of local adoption of new global policies/procedures.

- Identify critical processes (e.g., NPD) which are candidates for harmonization across franchises and/or sites.  Faciliate efforts to harmonize.

- Establish feedback loops between local implementation teams, EUDAMED workstream, and related EUMDR workstreams to ensure global policies & procedures are corrected/improved.

- Create and oversee mechanism for sharing process best practices, templates, work instructions, etc between franchises and/or sites.

- Identify and resolve gaps in EUDAMED related process training.

- Chair regular project progress review meetings with project team and site level teams.  Promote team working to facilitate the overall success of business-as-usual process deployment.

- Coordinate with QA representatives to ensure the GDIP process is leveraged to drive delivery of new/updated global and local policies and procedures.

Change Management (40%)

- Create and maintain franchise/site stakeholder map including site level functional leads, process owners, subject matter experts

- Franchise/site level: for new processes, ensure business process owners are established/agreed/institutionalized

- Global level: for new processes, ensure business process owners are established/agreed/institutionalized

- Utilize project dashboards/scorecards to present an overall view on the project for management and key stakeholders, highlighting major risks and escalating issues as appropriate to facilitate decision making

Systems Testing (20%)

Support EUDAMED core team to

-  Identify EUDAMED related systems testers.

-  Identify test scenarios and provide input to test scripts

-  Train testers and Business-as-usual users

-  Faciliate site level hypercare

Education:  bachaelor's degree in STEM field, or an equivalent combination of training and experience in Quality, R&D, Operations, or Regulatory disciplines.

Licenses/ Certifications: N/A


-  4-5 years work experience in functional area of work stream

-  Prior organizational change experience a plus

-  Demonstrated success in working with cross-functional teams. Strong process orientation, problem solving and troubleshooting skills

-  Ability to interface and influence at multiple organizational levels

-  High degree of self-motivation and excellent communication and interpersonal skills. Demonstrated experience in performing under tight timelines

-  Strong project management skills, particularly with respect to the organization, prioritization, and time management

-  Ability to work effectively with a range of business stakeholders from senior management to team members completing set tasks.


-  Microsoft Office Suite: Word, PowerPoint, Excel, Outlook, Project, Visio

-  Strong inter-personal and analytical skills.

-  International or cross-cultural work experience.

-  Flexible, able to manage changing priorities and willing to step up to requests in and outside of area of direct responsibility

-  Fluent in English

Physical Demands:

Work in an office with a high degree of PC work and meeting attendance.

Flexible working hours as required to deliver projects across US and European time zones

Travel Requirements:  Estimated 10–25%