Posted in Information Technology 30+ days ago.
This job brought to you by eQuest
Location: Cordova, Tennessee
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
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%