US-MA, Project Manager Regulatory
• Direct and manage regulatory approvals and ensure the approvals are stored appropriately.
• Define goals and deliverables that support business objectives in collaboration with the team.
• Develop processes and structure for the information flowing into and out of the database.
• Identify opportunities for improvement for future growth.
• Manage the resources needed to achieve project goals.
• Identify and resolve issues and conflicts within the project team.
• Proactively manage changes in the project scope, identify potential issues, and devise contingency plans escalating as appropriate.
• Establish the process of company integration into the database and provide oversight of the day to day operations.
• Support the entity integration around the world.
• Maintain good relationships with Regulatory Authorities, Regulatory Departments and distributors and provide support to worldwide partners.
• To control expenditure within assigned budget.
• Accountable for ensuring that all appropriate Quality and HR policies/procedures are communicated, implemented and adhered to in a fair and consistent manner within the Regulatory Department.
• Problem resolution of business partner concerns and project constraints.
• Bachelor’s degree required; Master’s Degree preferred
• Green Belt or Black Belt six-sigma certification a plus
• Demonstrated relevant project management experience a must
• Global Project leadership experience required
• Excellent cultural awareness
• Regulatory experience in medical device industry a plus
• Experience influencing and managing others
• Very strong organization skills
• Ability to work at both a macro and micro level as required
• Ability to translate complex situations into simple working solutions
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