- Title: Regulatory Affairs Project Manager
- Code: RCI-FSP-28398240
- Location: Raynham Massachusetts (MA) 02767
- Posted Date: 10/08/2019
- Duration: 1 Years
- Name:Prince Dash
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 234
Oversee all regulatory aspects of the MDR program (regulatory management).
-Experience. working on European submissions
-Experience working with cross functional teams
-Experience leading teams
-MDR (med device regulation/not reporting)
• 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.
• 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