Regulatory Project Coordinator

The Fountain Group is a national staffing firm currently hiring for a Regulatory Project Coordinator opportunity with one of our prominent clients located in Alameda, CA 94502 within their Diabetes Care business unit.

This is a great opportunity for someone with medical device experience and a background in project coordination and regulatory compliance. Most projects will focus on regulatory compliance initiatives, while supporting more senior-level Project Managers and working closely with cross-functional teams.
 
Position: Regulatory Project Coordinator
Business Unit: Diabetes Care
Schedule: Monday – Friday 8:00am – 5:00pm 100% onsite
Pay: $30 - $36 per hour to start
Job Type: 11 ½ month contract to start with possibility of extension or conversion based on performance and budget.
 
What You'll Be Doing:

• Support senior Project Managers with regulatory compliance and medical device-related projects.
• Coordinate project activities, milestones, deliverables, action items, and deadlines across multiple projects.
• Work closely with cross-functional teams and stakeholders to keep projects on track.
• Track project plans, schedules, risks, dependencies, and outstanding action items.
• Follow up with team members to ensure deliverables are completed on time.
• Support project meetings, documentation, status updates, presentations, and reporting.
• Assist with projects involving regulatory and compliance requirements, including FDA and EU MDR.
• Maintain project trackers and documentation using tools such as MS Project and Smartsheet.

• Medical device industry experience is required.
• Approximately 2+ years of project management, project coordination, or program support experience.
• Candidates with 6 months–1 year of internship experience may be considered if the internship was within a medical device company.
• Experience with regulatory compliance, FDA compliance, EU MDR, MDR, or ISO 13485 is highly preferred.
• Bachelor's degree preferred. Candidates without a degree may be considered if they have strong medical device and regulatory compliance experience.
• Strong experience working with cross-functional teams.
• Excellent organization, follow-up, communication, and attention to detail.
• Experience with MS Project, PowerPoint, and/or Smartsheet is preferred.
• Comfortable supporting multiple projects and working in a fast-paced environment.

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