The Quality Systems project manager for EUDAMED will oversee the creation & implementation of the QMS process for EUDAMED within my client's organisation. The role requires a comprehensive understanding of regulatory requirements, strong technical writing skills, strong project management skills, and the ability to coordinate cross franchise teams to ensure compliance with EUMDR & IVDR.
The role & Key Responsibilities:
* Develop & manage project plans , timelines and budgets .
* Co-ordinate with internal and external stakeholders to ensure all milestones are met
* Identify, manage and mitigate project risks and issues.
* Ensure the organisations data submissions to EUDAMED comply with EUMDR requirements.
* Stay updated on regulatory changes and provide guidance on EUDAMED – related compliance matters.
* Collaborate with quality assurance, IT and other relevant departments to ensure seamless integration and operation of EUDAMED processes.
* Develop and deliver change management processes to maintain data integrity
Qualifications and Experience:
* A minimum of a Bachelor's Degree, preferably in Engineering or related technical field. Generally, requires 10 years related experience.
* Experience working in both an FDA and European regulatory environment is preferred.
* This position will require relevant experience working in manufacturing/operations.
* In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
* Experience with a proven track record of implementing appropriate risk mitigation.
* Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
* Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
* The ability to perform "hands on" troubleshooting and problem solving is preferred. The ability to think on the feet and providing sound judgment is highly desired.
* Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
* A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
* Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.
* Demonstrated project management and project leadership abilities are preferred.
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