Posted to MedZilla on 3/5/2017


ProClinical

US-MA, Project Manager Regulatory


 
 

RESPONSIBILITIES


• 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.


QUALIFICATIONS


• 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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