Job Description

Top 3 things the manager is looking for: 

1. Advanced Excel skills for monitoring and tracking data. Ability to synthesize and create reports from the data
2. Detail oriented with exceptional follow-up/follow-through discipline      
3. 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

Top 3 Tasks or Responsibilities in scope for this role:

1. Plan global regulatory submissions

2. Track data to monitor and follow-up on timelines

3. Report status of timelines to stakeholders

Education Required:  College degree

Years’ Experience Required:  3-5 years 
Location: Remote 

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

Must Have: 

• Administrative/project support experience 
• Advanced Excel skills

Job Tags

Contract work,

Similar Jobs