ABBOTT LABORATORIES Program Manager - IVDR (In Vitro Diagnostics Regulation) Salary in the United States

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

Position Overview:

Abbott Diagnostics is looking for a qualified and motivated leader to organize the global team responsible for the successful transition to compliance with the European Union In Vitro Diagnostics Regulation (IVDR). This individual will be a leader for the overall division program and the subject matter expert for program management and implementation of best practices. 

Responsibilities:

• Responsible for management of the integrated project plan and timeline for the IVDR program including quality management systems implementation, product change planning and execution, product submission and global re-registration, and commercial launch.
• Makes and meets aggressive commitments to achieve plans and maintain progress. Establishes program goals and implementation plans.  Engages the team in the development of detailed timelines including resource requirements, duration estimates, risks, contingency plans, etc.
• Effectively manages communications for a geographically dispersed team with representation from multiple cross functional areas. Identifies and communicates issues and solutions; presents information to others in a manner that supports organizational objectives; identifies the appropriate recipients for information. Demonstrates responsibility for ensuring the information is received and understood by the recipient.
• Implements tools and establishes work processes to enable the teams to improve communication and the decision-making process with increased focus on critical tasks.  Recommends and implements innovative ways to improve program performance.
• Expertise and Problem Solving Duties:
• Coordinate input from multiple areas or multiple project managers on related projects.
• Develop project specifications and objectives, strategies, timelines and milestones/design and development plan. Utilize project scheduling software to plan and track projects.

• Identify resource requirements, cost, and time schedules. Develop an implementation plan, conduct risk assessments and develop contingency plans to accommodate unforeseen events.

• Lead cross-functional teams through project planning exercises to develop detailed schedules and integrated project plans.

• Define the nature of the stated business or technical problem.

• Develop alternatives to major business problems.  Assist management in selecting the specific action plans that will best meet the identified long-term business issues.

• Anticipate long-term future problems, resolve current issues, learn and adjust based on prior results and prior project leadership experience.

  Assure that projects will effectively integrate with existing programs and strategies so that long and short term business goals are attained.

  Recognize the broader implications of actions and proposals on the final project outcome, related systems and activities, and general business strategy.

  Prepare and present project progress reports to keep management and team informed. Identify problems, their resolution, trends, and their impact on project success; propose recommendations for management action.

  Analyze date for true causes of problems.

  Accountability/Required Supervision:

  Negotiate project outcomes and deliverables to meet the conflicting demands of time, money and deadlines.

  Maintain project expenses within budget.

  Drive cross-functional teams to meet milestones and deliverables established in project planning and agreed upon with senior leadership.

  May function as the project contact with third party vendors.

  Provide leadership on strategic business issues.

  Accountable for the total project scope; completion within budget constraints and scheduled completion date.

  Accountable for the successful completion of project tasks under direct or matrix control.

  Level loads work to ensure effective use of available resources.

  Leadership Activities:

  Solicit the cooperation of a diverse group of disciplines and functions in a tactful and persuasive manner.

  Lead others in the completion of project tasks.

  Manage a cross-functional team which may consist of senior level individual contributors.

  Manage the decision-making process.

  Is the final decision-maker for conflicts when in context of agreed upon project plan.

  Creates a work environment that supports team effectiveness. Provides feedback to team members on performance.

  Level of interpersonal skills:

  Interact with senior level management to reach agreement regarding significant program strategies.

  Interface with other disciplines, customers, internal clients, and project staff and internal/ external experts as required.

  Prepare and presents written and oral reports and other presentations to internal and external audiences. Adjusts presentation style and content to suit the audience.

  Negotiate resources, both human and financial.

Minimum Qualifications:

• Knowledge of regulations and standards affecting IVDs (In Vitro Diagnostics) and Biologics.
• Bachelor’s Degree in a discipline appropriate to the project environment. Advanced degree is preferable.  
• Minimum ten years relevant experience.
• Has successfully led several high complexity projects from beginning to end. 
• Demonstrated technical skills and management judgment appropriate to the project.

Preferred Experience, Education, etc.:

• PMP Certification
• 10 or more years of above experience CE-marking process for IVD (In Vitro Diagnostic) medical devices.