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PMO Lead

Exaways Corporation

 

Santa Rosa, CA, USA

Posted On: 3 days ago
Experience: 8+ years
Availability: Onsite
Openings: 2
Category: PMO
Tenure: No Preference/Any
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Description

Head the onsite account for the Medical Business Unit, managing project deliverables, stakeholder service, and operations.

This role is on-site.

Responsibilities

  • Direct and manage all service delivery activity and support functions for Medical BU needs.
  • Oversee operations and deliverables to improve efficacy and maximize business unit throughput.
  • Manage and mitigate risks across technical, operational, and customer servicing processes.
  • Partner with Sales to execute solutions for existing and new customers to drive growth.
  • Lead employee engagement, personnel development, and workplace culture.

Required Skills

  • 8+ years of experience in a similar role within the IT Services or Software industry.
  • Hands-on knowledge of ISO 13485, ISO 14971, IEC 60601, and IEC 62304.
  • Proficiency with FDA QSR, FDA 21 CFR Part 820, and EU MDR.
  • Knowledge of REACH and RoHS standards.
  • Experience managing delivery and operations specifically within the medical devices or regulatory space.
  • Experience managing cross-functional global R&D teams in a matrix environment.
  • Strong background in the product development lifecycle for safety-critical medical devices.
  • Proven ability to manage stakeholder expectations and meet aggressive deadlines in agile environments.

Preferred Skills

  • MBA in General Management.

Education

ANY GRADUATE

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