Vision Achievement is hiring on behalf of Oriel STAT A MATRIX.
Oriel STAT A MATRIX is a leading US based Quality and Regulatory consulting and education company focused on medical devices and in vitro devices. This role is for a 6 months contract that can be extended.
This is a key role and will provide medical device Labeling integration and project management for a device manufacturer. Work with operations, supply change, vendors, quality, regulatory to define and establish a labeling process that will meet word wide regulations but still will allow the company to have a flexible supply chain.
Principal Responsibilities will include (but are not limited to) the following:
- Leading and managing multi-discipline teams to transition sites from current practices, processes and systems for labeling design, development, translation, and implementation through change management for maintenance.
- Spearheads the standardization of processes to meet new and evolving global labeling requirements using creative approaches.
- Coordinates labeling design and execution for global labeling changes while interfacing with SMEs, site leads, site operations and other functions to define scope, and objectives, and project plans in accordance with client’s business and compliance goals.
- Coordinates the review and release labeling for product labels, cartons and other related materials, ensuring appropriate review by the relevant SME(s) regarding medical, legal, and regulatory requirements for medical devices
- Ensures proper communication of project at site level in partnership with operations, quality, regulatory, planning and marketing to ensure project success.
- Applies Best Project Management practices to management large projects across multiple sites and functions to:
- Provide updates, reports, establish, monitor KPIs and progress while identifying risks to overall project plan.
- Track project costs in order to meet budget
- Monitor progress and adjust as needed
- Measure project performance to identify areas for improvement
Job Qualifications
- Bachelor's degree in related field such as (Engineering, Scient or other applicable degree)4 - 5 years’ experience in highly regulated industry or medical device, pharma or similar industry with experience leading large projects.
- 2- 3 years of project management skills and experience in the medical device field.
- Strong people management experience and interpersonal skills.
- Deep knowledge of supplier / vendor relations and medical device industry best practices.
- Experience working on multi-disciplinary teams with demonstrated evidence to drive change by influencing all levels of the organization
- Experience with integrating medical device labeling global requirements into an organization’s Quality Management System
- Strong familiarity with project management software tools, methodologies, and best practices
- Excellent analytical skills
- Proven ability to complete projects according to outlined scope, budget, and timeline
- Effective verbal and written communication skills both in Hebrew and English
- Experience in production planning, operational management. supply chain - Advantage
- Knowledge of medical Regulatory standards (ISO 13485, FDA CFR21 820/11)– Advantage
To apply: https://www.careers-page.com/vision-achievement/job/L8X7W7X3
