This role works across all client Surgery functions to lead the transition to new compliance regulations for the European Union (EU),EU MDR and coordinate activities with client synergies and NPD to assure seamless integration.
The role will coordinate with multiple functions including R&D, Packaging, Operations, Regulatory and Quality.
Knowledge of design control, Restricted Substances, Design Quality, Biocompatibility and Risk Management are required.
You will be responsible for ensuring that the corresponding sub-stream achieves readiness for the distribution of EU MDR compliant product as well as all other defined deliverable within the established program timelines.
You will be successful by partnering with EU MDR team members as well as Synergy and NPD program leaders to ensure process/procedures, organizational changes and system updates have been modified and the affect of all programs are considered.
This role is a 15-20-month duration based assignment.
Responsible for maintaining all active project plans in MS Project (or other similar PPM software) and will be responsible for helping client associates to learn and adopt these technologies.
Experience
Must have previous experience as Program Manager in medical device field for a minimum of 7 yrs. in the area of NPD.
Extensive experience with US and EU regulatory systems and requirements is essential to the position as well as technical knowledge of operations execution.
The role will work across multiple functions in the transition to new compliance regulations for the European Union (EU) and implementation of all requirements at the Business Unit (BU) as well as manufacturing sites. .
Qualificatiions & Skills
Bachelors degree in related field (business, engineering, or related analytical field).
6+ years of project management.
History of working in a shared service or BPO organization.
Mastery skills in understanding the business, being agile and applying expertise in communication and working with diverse groups of people and skill sets.
Mastery of project scheduling skills and use of PPPM software (like MS Project, and Project Server).
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