Job Details

  • Title: Regulatory Affairs Project Manager
  • Code: RCI-FSP-28398240
  • Location: Raynham Massachusetts (MA) 02767
  • Posted Date: 10/08/2019
  • Duration: 1 Years
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  Job Description

Job Description:

Oversee all regulatory aspects of the MDR program (regulatory management). 

Must Haves:
-Experience. working on European submissions 
-Experience working with cross functional teams
-Experience leading teams 
-MDR (med device regulation/not reporting)

PRIMARY RESPONSIBILITIES:
• Set deadlines and monitor progress of project.
• Prepare reports for upper management regarding status of project.
• Assign responsibilities to others.
• Mentor junior staff. 
• Maintain various tracking logs to ensure project stays on schedule.
• Escalate delayed activity to Regulatory Affairs Management.
• Work with cross-functional teams to gather required documentation.
• Review documents from various sources for completeness.
• Compile regulatory submissions.
• Other various related activities.

QUALIFICATIONS:
• Microsoft Outlook & Calendar Management, Excel Spreadsheets, Microsoft Word and PowerPoint Presentations – able to create reports and manipulate data
• Knowledge of Adaptiv software (preferred)
• Understanding of compliance and regulatory requirements 
• Ability to work independently with limited supervision
• Strong analytical skills
• Flexibility – able to adapt to compliance cycle activities and demanding timelines
• Strong team player – will need to collaborate with Regulatory Affairs team, and other functional team members (on conference calls & in-house meetings)
• Excellent written and verbal communication, and the ability to communicate effectively with all levels of the organization