Description


Job Summary The Regulatory Affairs Coordinator works under the direction of the Associate Director in the Regulatory Affairs department to run projects related to regulatory affairs. The Regulatory Affairs Coordinator supports the project stakeholders by facilitating project logistics such as project scheduling, timelines, administrative tasks, creating presentations, flow charts, facilitating meetings, conference rooms, conference calls, etc. As well as, take meeting minutes and action items during meetings and perform basic follow-up. The Regulatory Affairs Coordinator supports project teams by facilitating project logistics and supporting key aspects of small and / or medium-complexity cross-functional programs. The Regulatory Affairs Coordinator leads multiple projects, and independently manages projects of small / medium complexity. They should feel comfortable leading many regulatory coordination tasks with little to no oversight. The Regulatory Affairs Coordinator should be comfortable in leadership roles, be able to condense information into a cohesive plan, and be able to effectively communicate and execute plans.
Principal Job Duties and Responsibilities

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  Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics\xe2\x80\x99 Quality System.
• Facilitate meetings, take meeting minutes, record action items and key decisions.
• Assist department management in recognizing and executing project requirements.
• Assist with regulatory project communication to align stakeholders and track goals/milestones.
• Run regulatory program meetings independently.
• Draft project proposals, project plans, schedules, timelines, presentations, graphs/charts, workflows, technical reviews, etc.
• Use project scheduling and control tools to monitor project plans and scheduled milestones.
• Analyze relevant information (i.e., project status, project issues, etc.); suggest solutions to potential roadblocks.
• Effectively and accurately communicate relevant project information to project team.
• Maintain project documentation and ensure that appropriate documentation is complete at project closure.
• Communicate with cross functional stakeholders to assess and meet regulatory program milestones.
• Work collaboratively cross-functionally.
• Independently manage small, medium complexity projects.
• Teach and/or mentor other members of the team.
• Propose new ideas/solutions to regulatory management.

Training or Education
Bachelor\xe2\x80\x99s degree in a Life Science, Project Management, or related field, or equivalent work experience. Experience Two to three years of project coordination experience. Experience working for a medical device company a plus. Knowledge, Skills, and Abilities

• Clear and transparent communication skills, both orally and written.
• Effective organization and excellent attention to detail.
• Critical listening skills and an ability to recognize important and high-level information.
• Proactive process improvement skills.
• Intermediate proficiency using Word, Excel, Visio/Lucidchart, and PowerPoint.
• Ability to prepare clear and concise summaries for stakeholders and management.
• Self-motivated, and able to manage time effectively.
• Ability to understand multiple perspective.
• Can effectively work as part of a team and supports the team with a helpful attitude.
• Ability to stay positive and calm in stressful situations.
• Ability to adjust to changes in scheduling, and general flexibility in the work environment.
• Comfortable with ambiguity.
• Critical listening skills, and an ability to recognize important and high-level information.