Regulatory Project Coordinator Jobs

MDR- Project Coordinator III (Regulatory) (Through end of April 2024 // REMOTE, team based in MA):

Top Skills:

1. Monitoring and tracking data using Excel and/or SmartSheet
2. Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools
3. Detail oriented with exceptional follow-up/follow-through discipline
4. Communicating with a wide variety of stakeholders including (and especially) with stakeholders in countries outside the U.S.

*W2 Candidates ONLY*

Description:

Seeking to hire a Regulatory Project Coordinator III to join the client’s Surgical Operating Unit. In this role, candidate will be providing support for the EU MDR Program related to the regulatory activities necessary to achieve global replenishment of MDR approved devices.

Duties:

• Identifies issues in data and/or documents which require action, recommends alternatives, and executes an alternative when appropriate
• Tracks project timeline and global regulatory submission data
• Monitors, analyzes, and communicates data using Excel, Power Point, shared network drives, Teams, etc.
• Maintains file-specific correspondence and other required documentation
• Manages schedules, reviews status of projects, and prepares status reports on an ongoing basis
• Ensures timely and quality completion of regulatory data forms verifying data as well as identifying, managing, and resolving data discrepancies
• Works under general supervision
• Supports process improvement efforts to enhance systems and reduce lead time
• Solves problems of moderate scope and complexity following established policies and procedures
• Attends meetings, takes notes on discussion points and action items, ensures proper follow through

Must Have:

• High School Diploma or equivalent
• 4 years of administrative/project support experience