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Program Director, MDR Labeling Operations

Company: USA - Smith & Nephew, Inc.
Location: Memphis
Posted on: January 16, 2020

Job Description:

SUMMARY Reporting to the Senior Director, Global Packaging Technology, the role will be responsible for the management of the Labeling Operations workstream within the EU MDR program. The MDR workstream lead will ensure that the labeling and packaging requirements of the MDR legislation are correctly interpreted, specified and implemented within the functions that the workstream represents. This is a major change management and leadership role; including workstream definition, project planning, milestone scheduling, delivery, and administration of project team activities. This is a global role and will be responsible for coordinating teams of different sizes across multiple S&N sites to deliver the workstream scope within the agreed timeline. The individual will have relevant business knowledge of medical device packaging and labeling and MDR legislation in addition to strong change management, process development, project management and leadership skills. The individual will manage the staff and MDR compliance process in their relevant work stream as well as working with the other workstream leaders to deliver the cross-functional processes for overall MDR compliance within a matrixed program organization. - LOCATION : The strong preference is for this person to be based in Memphis, but for the right candidate we will consider Andover, MA or Austin, TX. ESSENTIAL DUTIES AND RESPONSIBILITIES: Defines and delivers the MDR workstream specific requirements, scope, plan and approach. The individual will manage the teams responsible for the key work stream processes, ensuring we meet the MDR compliance objectives building in the new MDR regulations with input from the regulators (notified bodies), competent authorities and S&N stakeholders. The role encompasses both high level strategic management and also management of teams establishing and maintaining many essential processes, keeping products compliant with legislation and allowing products to be maintained in the market place. This individual needs strong influencing skills at all levels of the organization and is responsible for ensuring the MDR management team and sponsors are fully informed around the current status of MDR compliance within the workstream. Work with other work stream leads in the MDR core team to lead decision making, cross functional thinking and progress the project. Identifies business process stakeholders and works with them to communicate progress, process changes, risks and issues relevant to the MDR Workstream. Identifies and resolves complex technical, operational and organizational challenges related to MDR. Identifies and delivers the relevant training approach for the workstream ensuring that S&N corporate standards are applied. Work with external suppliers where required to ensure the workstream deliverables are met Establish regular communication channels for stakeholders and multiple teams across S&N sites. Manage the workstream budget. Must have strong documentation skills with attention to detail. Breakdown of Position Functions - Accountable for the development, implementation and running of the Labeling Operations work stream which not only fulfills the program deliverables but also S&N's legal obligations and ensures business process improvements are driven forward - 30% Manages team responsible for MDR compliance for Labeling Operations and delivering to an agreed plan and milestones - 30% Reports back to the MDR management team on progress against the work stream plan. Identifies roadblocks and recommends / implements solutions to keep the project on track - 20% A key role of this individual's team will be to interpret the developing MDR legislation and implementing acts to gain and remain MDR compliant. - 10% At a functional level the individual is also responsible for the development and execution of strategy within their workstream - 10% FOR SUPERVISION: Supervise all members of the labeling operations work stream. These individuals will maintain a dotted line reporting relationship into the functional managers of each respective packaging, labeling, and/or Tech Comm function. FOR INTERNAL AND EXTERNAL RELATIONSHIPS: Extensive contact required with other S&N departments, divisions, and business units. External suppliers or regulatory authorities where relevant to the workstream FOR ORGANIZATIONAL INFLUENCE: Works with key areas in determining and setting direction for the MDR program across Smith & Nephew. Position has considerable influence on MDR compliance, company policy, processes, and procedures. **Smith & Nephew is an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status**

Keywords: USA - Smith & Nephew, Inc., Memphis , Program Director, MDR Labeling Operations, Executive , Memphis, Tennessee

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