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.
Abbott Diagnostics is looking for a qualified and motivated individual to join the team responsible for the successful implementation of UDI (Unique Device Identification) process for CE-marked products for the European Union In Vitro Diagnostics Regulation (IVDR). This individual will lead the planning, project management and implementation of the IVDR UDI requirements for the Abbott Diagnostics Division.
- Responsible for management of the integrated project plan and timeline for the IVDR UDI program.
- Core member on the IVDR cross functional team to ensure IVDR UDI and overall IVDR project plans align.
- Makes and meets commitments to achieve project plans and maintain progress. Establishes project goals and implementation plans for IVDR UDI. Engages with the IVDR team in the development of detailed timelines including duration estimates, risks, contingency plans, etc.
- Effectively manages communications to the IVDR team for UDI updates. Identifies and communicates issues and solutions; presents information to others in a manner that supports IVDR UDI objectives; identifies the appropriate recipients for information. Demonstrates responsibility for ensuring the information is received and understood by the recipient.
- Assist in establishing work processes to incorporate the IVDR UDI process. Recommends innovative ways to improve project performance or alternate paths for implementation.
- Cultivates relationships with colleagues by developing an understanding of others' needs, promoting common goals, and following through on commitments. Promotes productivity cross-functionally by exchanging information with appropriate frequency and timeliness to maximize its utility.
- General - Defines project goals and milestones.
- Responsible for timely project completion.
- Provides solutions to a wide range of difficult problems.
- Ensures that solutions are compliant, innovative, thorough, practical and consistent with organizational objectives.
- May lead projects with cross-functional or broader scope.
- Interacts effectively with employees, manager, and cross-functional peers.
- May represent own team while on cross-functional project teams with other functional leaders.
- Communicates confidently and effectively with management, peers, and key stakeholders.
- Implements tactical solutions related to assignment.
- Able to contribute functional skills and expertise broadly.
- Directly influences project direction and scope.
- Ensures compliance to site level policies and procedures and demonstrates a solid understanding of Division and Corporate policies and procedures by promptly addressing noncompliance issues within Division and Corporation as appropriate.
- Receives general direction and exercises considerable discretion to own work detail.
- Recommends possible solutions.
- Decisions may have short and long-term impact.
- Bachelor's degree or equivalent technical experience and demonstrated competence; additional post-graduate education may contribute toward the desired years of experience;
- Typically requires 3-5 years of experience in complex, technical program / project management to develop the competence required to meet the skills and responsibilities of the position;
- Candidates / incumbents should possess the following:
- skilled in project planning and management;
- strong decision-making and problem-solving skills; demonstrated good judgment;
- working knowledge of new product development methodologies;
- ability to be creative in achieving objectives while assuring compliance to internal and external requirements;
- ability to utilize commonly accepted project management tools to assist in the development of and adherence to a schedule;
- ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors;
- ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior;
- ability to work independently and in groups; ability to work cross-functionally;
- ability and aptitude to use various types of databases and other computer software;
- ability to prioritize.
- Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), engineering, or medical fields is preferred.
- Demonstrated success in leading projects, PMP desired.
- 5+ years of experience in regulatory affairs, quality assurance, research and development, product support or related area.
- Previous UDI experience is helpful
- Knowledge of EU IVDD and/or IVDR