Regulatory Project Coordinator

Primary Talent Partners; Minnesota; Remote; USD 60,000 - 80,000; Full time

Job summary

A leading medical device company is seeking a Regulatory Project Coordinator to support its EU MDR Program. This fully remote position involves managing regulatory data timelines and documentation, making it ideal for candidates with strong Excel skills and a detail-oriented approach. Join a dynamic team focused on advancing regulatory processes in the healthcare space.

Qualifications

• 3-5 years of administrative/project support experience.
• Detail-oriented with exceptional follow-up discipline.
• Ability to communicate with diverse stakeholders.

Responsibilities

• Ensure timely completion of regulatory data forms and manage discrepancies.
• Track project timelines and maintain required documentation.
• Facilitate meetings and accurately document discussions.

Skills

Advanced Excel skills

Attention to detail

Communication with stakeholders

Education

High School Diploma

College degree

Tools

MS Office applications

Job description

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Primary Talent Partners provided pay range

This range is provided by Primary Talent Partners. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$30.00/hr - $40.00/hr

Primary Talent Partners has a 10-month contract opening for a Regulatory Project Coordinator to join a large medical device company for a fully remote position.

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


Job Description:
We are excited to hire a Regulatory Project Coordinator III to join our *** 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

Top 3 Tasks or Responsibilities in scope for this role:

Plan global regulatory submissions

Track data to monitor and follow-up on timelines

Report status of timelines to stakeholders

Must Have:

• Administrative/project support experience
• Advanced Excel skills

Education Required: High School Diploma required, College degree highly preferred

Years’ Experience Required: 3-5 years

Top 3 things the manager is looking for:

Advanced Excel skills for monitoring and tracking data. Ability to synthesize and create reports from the data

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. Experience hosting meetings and writing accurate meeting minutes

Nice to have skills:

• 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 [e-mail]

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Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Contract

Job function

• Job function

  Other

• Industries

  Medical Equipment Manufacturing

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