Job Description :
Hi,

There is an urgent requirement for the following. Please let me know your interest ASAP.

Position: Regulatory Affairs Project Manager (Medical Devices)

Location: Round Lake, Illinois





Project Manager to provide business and regulatory affairs leadership for a highly complex project supporting the transition from the EU MDD to the EU MDR and other regulatory needs across different global business units. This Project Manager will collaborate with cross functional stakeholders to drive to solutions/results in accordance with the project deadlines. This Project Manager will make commitments to businesses and manage stakeholder expectations about project deliverables during the program. Other activities include preparing or submitting documentation to authorities for medical device product submissions, assessing country impacts of regulatory changes and coordinating across business units with regulatory affairs leadership. This role will report to regulatory affairs leadership.



ESSENTIAL DUTIES AND RESPONSIBILITIES

· Accountable for core team performance, project schedule and on-time execution

· Leads team in defining project deliverables and operating mechanisms

· Provides clear direction on project to meet expectations of customers and business stakeholders

· Interacts through project updates and reviews with all stakeholders ensuring effective ongoing communications across teams and stakeholders

· Ensures identification and communication of project risks, development of risk plan and proactive management of risk response strategies

· Anticipates potential conflict situations for proactive solutions and manages conflict situations to result in win-win outcomes

· Work with cross functional teams to organize work and drive results



QUALIFICATIONS

· Business acumen

· Strong communication

· Strong in all aspects of project management

· Strong background in regulatory project implementations

· Ability to collaborate with regulatory affairs subject matter experts and define and drive tasks and work

· Experience working with regulatory affairs business leaders

· Direct experience with global regulations in EU and globally

· Must be able to assess validity of overall project strategy and deliverable s

· PMI or IPMA or equivalent certification desired

· Medical device experience required



Swati Singh

Technical Recruiter

Xchange Software Inc

10 Austin Avenue, Iselin, NJ - 08830.

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