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1+ months

EUMDR Project Manager

Kelly Services
Irvine, CA 92604
Kelly Science & Clinical is currently seeking a **EUMDR Project Manager** for a long-term engagement with one of our Global Med Device clients out of Irvine, CA


*****The employee will be asked to work in the office1-2 times a week, once Covid restrictions are lifted*****


This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.


**Job Duties:**

Provide project leadership to transition 30 plus regulatory technical files to MDR compliant Technical Documents for submission to the Notified Body.

Establish cross-functional project teams for each Technical Document. Identify team members and project scope.

Create detailed Project Plan for each TD to include deliverables, interdependencies, owners, and target due dates.

Create project kick-off presentations and lead kick-off meetings

Schedule and lead weekly and biweekly workstream meetings to monitor progress against Plans.

Publish meeting minutes including deliverable status and action items and follow-up on action items

Manage program budget and track expense against budget

Issue resolution

Identify project risks and escalate as appropriate

Maintain project and master trackers to track progress

Provide metrics for team presentations

Identify information needs, ensure information flows to appropriate functional areas, support document reviews/ approvals.

Maintain Program SharePoint to provide access to project information

Coordinate internal resources and third parties/vendors for the flawless execution of projects

Ensure that all projects are delivered on-time, within scope and within budget

Develop project scopes and objectives, involving all relevant stakeholders and ensuring technical feasibility

Ensure resource availability and allocation

Develop a detailed end to end project plan to track progress

Use appropriate verification techniques to manage changes in project scope, schedule and costs

Measure project performance using appropriate systems, tools and techniques

Report and escalate to management as needed

Manage the relationship with the execution team and all stakeholders

Perform risk management to minimize project risks

Establish and maintain relationships with third parties/vendors

Create and maintain comprehensive project documentation


**Qualifications Required:**

BS degree

1-3 years Quality/Compliance Experience in Medical Device

Min 1 year Project Management Experience

Excellent written and verbal communication skills

Excellent planning skills and ability to learn quickly, multi-task and handle multiple priorities

Excellent interpersonal/ influence skills

Excellent analytical, problem solving, process thinking skills

Strong computer skills with experience in Word, PowerPoint, Excel, Outlook, Microsoft Teams, (Microsoft Project is a nice to have).

Detail oriented

Can work independently and demonstrates initiative and resourcefulness

Drives to meet goals


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-05-21 Expires: 2021-07-22

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EUMDR Project Manager

Kelly Services
Irvine, CA 92604

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