Project Manager I in Maplewood, MN at Volt

Date Posted: 5/14/2020

Job Snapshot

Job Description

NON-IT Project Manager

ST. Paul-12+mth contract

$68.00 hr

Volt Workforce Solutions is partnering with an industry leader in medical device manufacturing to hire a NON-IT Project Manager

Job Duties:

  • Manages complex device projects within the B/U.
  • Assures the development of multi-level project planning to achieve short and long-term business objectives
  • Develops, tracks and reports on all key project deliverables.
  • Keeps senior management team informed of progress and issues.
  • Ensures project teams have appropriate resources to perform assigned tasks.
  • Reviews protocols and reports to support regulatory submissions.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  

Qualifications:

  • BA or BS degree (degree in a technical discipline highly preferred).
  • A minimum of 5 years of technical experience, including at least 4 years of regulatory experience in a medical device industry.
  • Experience with 510(k) applications, PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions.
  • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
  • Strong organizational, planning, and follow-up skills and ability to hold others accountable.

Volt is an Equal Opportunity Employer