Project Manager

3 weeks ago

Temecula, United States SPECTRAFORCE Full time

Title: Project Manager - Regulatory Intelligence

Duration: 12 months Contract

Location: Temecula, CA or Lillehei in St. Paul MN (ONSITE)


Ideal candidate:

  • Has led several mid-to high projects of varying complexity from beginning to end.
  • Can convey tangible program management skills and effective judgment 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.


Job Description:

  • Responsible for project management for 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:

  • 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


About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at:

Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

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