JOB DESCRIPTION
Description :
- Responsible for project management for Client Medical Devices implementation of EUMDR, through the final stages for EU certification, and our International roll out.
- Plans and directs schedules. Monitors the program / project from initiation through delivery, interfacing with customers on process, regulation interpretation, technical matters, and integration into the Quality System.
- Drives completion of the program / project to deliver on schedule.
- Present program strategies and updates to executive management and stakeholders.
Responsibilities include :
- Work with IT and a cross businesses and functional teams to deliver processes necessary to support EUDAMED activities and integrate that into our quality systems
- Collect, communicate, and ensure data accuracy in reporting project deliverable status
- Provide direction on regulation ensuring accurate understanding and interpretation of requirements and their impact
- Drive deliverables schedule based on established plans
- As applicable, gather lessons learned and share best practices across the organization
- Create and deliver project status report-outs (PowerPoint, Memos, meetings, etc.)
- Effectively deliver and adjust messaging across all levels of the organization
- Critical thinking and analysis used to identify, remove, and / or escalate roadblocks encountered
- Creates a work environment that supports team effectiveness
Ideal candidate :
- Has led several mid-to high projects of varying complexity from beginning to end.
- Can convey tangible program management skills and effective judgement demonstrated by successful program results.
- Outstanding communication skills.
- Strong analytical skills.
- Skills in using Excel and / or Power BI to communicate status of deliverables.
- PMP Certification preferred.
- Experience in a Regulated industry preferred. Experienced with domestic and / or international regulations a plus.
- Experience project managing processes supported with IT systems, data functionality, and external or internal business requirements a plus.
Required :
- Bachelors Degree in Engineering, life sciences or industrial technology preferred. Or an equivalent combination of education and work experience.
- 7+ years of experience in a project manager role preferred. Minimum of 3 years of experience required.
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