Secure the achievement of project deliverables within the expected quality, timelines and costs.Develop, review, track and provide input on deliverables and recommendation on project and coordinate schedule of activities to meet milestonesEstablish working relationships with project team members, key customers and stakeholders.Knowledgeable of relevant quality standards related to pharmaceutical supply chain: validation, equipment qualification, process validation, formulation, filling and packaging.Responsible for the management of the Labeling Operations workstream within the EU MDR program. As the MDR workstream lead ensured that the Design input requirements were aligned with labeling and packaging requirements of the MDR legislation are correctly interpreted, specified and implemented within the functions that the workstream represents.Worked as a major change management leader; including initiated workstream definition, project planning, milestone scheduling, delivery, and administration of project team activities. Ensuring all product related documentation submitted as part of a technical file is re mediated to standards required by the MDR legislation.Developed relevant business knowledge of medical device Product & regulatory & clinical requirements, cleaning, sterilization, packaging and labeling and MDR legislation in addition to strong change management, process development, project management and leadership skills. Identified 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. Provided R&D engineering support for Quality and MDR compliance activities including correcting quality problems in released product, compliance with the new regulations and standards, support for Regulatory re-submissions, and remediation of quality records. Work with external suppliers where required to ensure the workstream deliverables are met.Previously, managing a portfolio of (21+) active projects to ensure existing Vascular/Surgical Catheter products get re-certified to meet current /updated FDA, PMDA, Asian & Korean (APAC) regulations and standard operating procedures. Provided technical and team leadership to a portfolio of projects. This entailed planning, scheduling, assignment of work, and technical support within the project area. Generated a program plan that meets business objectives and the design control process, while maximizing resource efficiency.
Listed skills include Engineering, Systems Engineering, Program Management, Six Sigma, and 40 others.
