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, Memo's, 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:
Bachelor's 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.
