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Regulatory Project Coordinator

  • Full Time, onsite
  • Primary Talent Partners
  • Minnesota, United States of America
Salary undisclosed

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Primary Talent Partners has a 5-month contract opening for a Regulatory Project Coordinator to join a medical device company for remote position.

Pay: $30/hr - $40/hr
Contract: 12 months, extensions likely, conversion possible
Type: W-2, cannot support C2C or provide visa sponsorship

Job Description:
We are excited to hire a Regulatory Project Coordinator III to join our Medical Device client's Surgical Operating Unit. In this role, you will be providing support for the EU MDR Program related to the regulatory activities necessary to achieve global replenishment of MDR approved devices.
Responsibilities may include the following and other duties may be assigned:
  • Ensures timely and quality completion of regulatory data forms verifying data as well as identifying, managing, and resolving data discrepancies
  • Tracks project timeline and global regulatory submission data
  • Maintains file-specific correspondence and other required documentation
  • Attends meetings, takes notes on discussion points and action items, ensures proper follow through
  • Monitors, analyzes, and communicates data using Excel, Power Point, shared network drives, Teams, etc.
  • Manages schedules, reviews status of projects, and prepares status reports on an ongoing basis
  • Identifies issues in data and/or documents which require action, recommends alternatives, and executes an alternative when appropriate
  • Supports process improvement efforts to enhance systems and reduce lead time
  • Solves problems of moderate scope and complexity following established policies and procedures
  • Works under general supervision

Must Have:
  • High School Diploma or equivalent
  • 5 years of administrative/project support experience
  • Advanced Excel skills

Top 3 things the manager is looking for:
  • Advanced Excel skills for monitoring and tracking dat
  • Detail oriented with exceptional follow-up/follow-through discipline
  • Communicating with a wide variety of stakeholders including (and especially) with stakeholders in countries outside the U.S.

Nice To Have:
  • 5+ years of work experience as a project coordinator/administrative assistant
  • Associate’s or Bachelor’s degree preferred
  • Capable of working on multiple projects in a deadline driven environment - demonstrated skill under pressure
  • Excellent written and verbal communication, and interpersonal skills
  • Experience working in a highly-matrix, dynamic, and fast-paced work environment (ability to shift priorities & work plan based on department needs)
  • Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications
  • Strong prioritization and organizational skills

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at [email protected]

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