Regulatory Affairs Project Manager - Medical Device

Profile

Regulatory Affairs Project Manager - Medical Device

Duties: Responsible for implementing and maintaining the effectiveness of the quality system. Define the business results expected from a project. Is responsible for making recommendations for achieving those results: where results may be in terms of compliance with Design Control and/or Change Control policies; quality; time; scope and cost. Manage major/complex projects or combination of projects. Responsible for implementing and maintaining the effectiveness of the quality system. Lead the team through the translation of management and customer needs into project goals. Identify resource requirements; cost and time schedules and participate in the funding process. Develop implementation plans; conduct risk assessments; and develop and implement contingency plan to allow for and accommodate unforeseen events and changes in strategy. Maintain compliance with regulatory agencies; quality system; ethics policy and project goals. Assure that projects will effectively integrate with existing programs and strategies so that long and short term business goals are attained. Creates Project Charter: Establishes project scope by creating charter; which includes “Done” for the project; assumptions; necessary conditions and preliminary project risks. Creates Project Plan: Plans how the project timeline will be created. Develops appropriately detailed; cross-functional; realistic; and challenging timeline that include resource requirements and buffers. As information becomes available; updates project risks in charter and; as appropriate; includes this work in the project plan. Adjusts Project Plan: Works with cross-functional groups to ensure that buffers are managed appropriately. Adjust project plan when appropriate and reflects these changes in the timeline. Creates contingency plans; reflects this work in the timeline; and acts on them to ensure project quality and delivery are achieved. Provides updates to management as plans change. Integrates Multiple Project Plans: Establishes and reviews complex plans for multiple projects and/or activities; plans resource allocation and distribution; and works on improvement and development of new planning processes. Works to ensure that consistent training matrices exist for all PMs. Executes Project Plans: Executes project plans to meet project goals; incorporates technical; resource; and regulatory requirements into project plans. Continuously Improves: Recommends innovative ways to improve performance; quality and enhance profitability on an ongoing basis; modifies work processes and procedures in line with current ADD quality and regulatory requirements. Works with cross-functional team to resolve resource conflicts; allocations. Allocates Resources: Appropriately prioritizes tasks and allocates resources to achieve desired outcomes. Manages Change: Evaluates the impact of project changes and adjusts implementation activities to meet revised. Clearly communicates any changes and the impact to original plan within the project and across other groups. Identifies and removes organizational barriers to achieving results. Determine if results match requirements. Ensures that the necessary documentation is in place to meet quality and regulatory requirements. Assimilates disparate information from multiple sources; analyzes for trends; adjusts results and draws inferences. Resolves disparate information. Integrates Major Issues: Synthesizes organizational issues and underlying causes to make judgments; recognizes the impact and interconnections in the organization and/or system; develops and recommends alternatives that support project strategies. Ensures that consistency is maintained across project. Assure project requirements are met (i.e. Compliance; Design Control; etc.). Establishes and manages team charter including project timeline. Manage the decision making process. Participate in identifying project resource needs and funding. Negotiate with resource managers to resolve any resource limitations that cannot be resolved by the team. May function as the project contact with third party vendors. Participate on division-initiatives to identify process improvements to accelerate projects. Interface with other disciplines; customers; internal clients; project staff and internal and external experts as required. Prepare and present written and oral reports and other presentations to internal and external audiences. Interact with senior level management to present significant Program strategies and make recommendations. Actively Listens: Listens actively to acquire information and understand the other person’s viewpoint. Builds Relationships: Initiates and cultivates open; honest; and beneficial relationships with colleagues and customers by establishing rapport; developing an understanding of others’ needs; promoting common goals and following through on commitments. Resolves Conflicts within the Team and across other groups: Seeks out appropriate forum for conflict resolution. Faces conflicts and takes initiative to resolve them constructively; diverts tensions away from individuals and toward work issues; probes for root causes of problems; collaborates to find mutually beneficial solutions; proposes action steps and assists in implementation. Collaboratively settles disputes. Identifies Future Personal Development Needs: Translates changes in business goals and objectives into the skills; knowledge and experience needed for future work. Balances the time needed for accomplishing current work and planning and achieving development goals. Asks for and gives feedback on the strengths and development needs of self/others; creates a team environment that encourages continuous learning and growth. Recognizes opportunities to identify and develop employees through challenging and stimulating assignments. Establishes a Development Culture: Encourages the exchange of timely; direct; constructive feedback on strengths and development needs. Coaches; counsels and mentors others to improve performance. Exercises leadership within the team with close support from manager. Confronts issues in a constructive manner and at an appropriate organizational level. Drives for resolution of important issues. Actively shares resources; ideas; data to accomplish goals requiring cross-functional collaboration and support. Influences Outcomes: Uses constructive techniques to persuade; convince or influence others to follow a plan of action; influences across functions with authority; sponsors innovation and initiative among teams; inspires; measures; and rewards commitment and action across the project and other groups. Negotiates: Always seeks a win-win decision. Provides Direction: Uses project plan and communication from Management to provide a focused vision/direction for the team and motivates people to believe in it. Acts as a role model and leads by example. Evaluates Project Risk: Recognizes strategy; qualifies and evaluates risks; recommends actions and develops contingencies to respond to project issues. Provides Change Leadership: Recognizes and rapidly responds to changes in trends; market conditions and competitors as well as own organization’s strengths weaknesses. Maximizes the contributions of all team members. Supports the development of the team’s charter. Communicates connection to Organizational Mission. Encourages collaboration; works with team to clarify roles and expectations; works just as effectively as a member or as a leader. Promotes a Teamwork Environment: Leads team in planning; problem solving and using appropriate decision making processes. Celebrates success: Encourages the development of team-based rewards and recognition. Demonstrates task engagement behavior and creates environment to support team member’s efforts to remain engaged until task completion. Delegates tasks or projects to the team and provides appropriate authority; responsibility and direction to assist in overcoming obstacles to complete them. Manages Performance: Sets performance targets for the team and communicates performance review information to resource managers; helps the team understand metrics for evaluating performance. Achieves high performance; holds the team accountable for results; evaluates progress and achievement. Uses appropriate decision making tools to make timely decisions with the best information available within a team and across groups. Manages Crises: Identifies; authenticates; and responds to issues in a professional manner; assembles appropriate resources to deal with and resolve the situation effectively. Communicates to management; within a team and across groups. Provides risk assessments (both safety and project related) and communicates critical issues impacting product quality to management. Quantifies and evaluates risks; recommends actions and develops contingencies. Translates goals into the day-to-day activities necessary to accomplish them. Aligns with Strategic Directions: Identifies organizational opportunities to better align day-to-day activities with strategic directions. Anticipates Future Directions: Identifies trends to contribute to the development of business strategies; provides input to appropriate business areas.

Additional Information

Ref. 30953688

Company info

Abbott
1921 Hurd Dr Ms224
Irving
Texas
United States 75038-4313
Website : http://www.abbott.com