Job Description:

Sr. Regulatory Affairs Coordinator

Overview

Provide administrative, compliance and technical support to the Endologix Regulatory Affairs department

Responsibilities

Administrative


• Issue purchase orders and process department invoices via Coupa and maintain department office supplies.


• Independently complete compilation, formatting, quality checks and publishing of both paper and electronic regulatory submissions for US and international filings.


• Initiate document change processes (DCO, NCO, CERTs, etc.) in MasterControl and coordinate collaboration and approval processes.


• Maintain department hard-copy and electronic files, external website use and access (FURLS, GUDID, etc.), and Pulse intranet.


• Maintaining calendars and schedule/coordinate meetings, appointments, and training.


• Support presentation development, scorecard updates, and department organization charts.


• Schedule and coordinate department and group meetings.


• Interface with and support other Regulatory Affairs team members as requested. 




• Compliance
  
  
  • Perform Quality Assurance reviews of processed device tracking information.
  
  
  • Prepare and distribute device tracking status reports to Sales personnel and FDA district offices.
  
  
  • Coordinate and compile approval documentation for special access cases.
  
  
  
  


• Technical Support
  
  
  • Support maintenance of global regulatory approvals and actions via the NORA process.
  
  
  • Support maintenance of external standards library and technical review process.
  
  
  • Understand RA Ops processes sufficiently to make recommendations for improvement and develop methods for implementation of improvements.
  
  
  
  

Qualifications

• Ability to develop a working knowledge for relevant medical device regulations.


• Must be detail oriented and demonstrate basic technical writing abilities.


• Good interpersonal skills including ability to interact with internal staff and external customers with a high degree of diplomacy.


• Ability to work in a fast-paced, technically challenging environment.


• Must be self-motivated and self-disciplined and able to prioritize and handle and solve multiple tasks and responsibilities.


• Must demonstrate effective problem-solving techniques, critical thinking skills, and basic math skills.


• Must have strong communication and organization skills.


• Expertise in Microsoft Word, Excel, PowerPoint and Visio programs.


• Experience with MasterControl, QAD, SalesForce, and Coupa preferred.