Regulatory Engineering Change Control Specialist
2 weeks ago
Our client, a Global Leader in the Medical Device Industry, has an immediate opening for a Regulatory Engineering Change Control Specialist for a 12-month + Contract.
This role will directly support our client's EUMDR project on Site.
Key Responsibilities:- Periodically work independently with vendors.
- Create and manage Engineering Change Requests as well as product impact assessments.
- Manage Engineering Change Notices for process changes from creation to final approval.
- Demonstrate a general understanding of Product Part Approval Process (PPAP) and First Article Inspection (FAI) process.
- Periodically lead projects and processes; work with cross-functional teams to get these projects completed.
- Investigate Quality issues for root cause and recommend/implement corrective actions.
- Ability to oversee team members' workload and provide support when issues arise.
- Bachelor's Degree in Engineering or relevant field of study.
- 1-3 years' experience in a production/manufacturing environment.
- Demonstrated computer skills using Microsoft Office applications (Word, Excel, PowerPoint, Project, etc).
- Experience in a Quality Management System and UDI/MDD/MDR/UKCA Regulatory Compliance project is preferred.
- Demonstrated interpersonal, communication, and presentation skills.
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Regulatory Engineering Change Control Specialist
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Regulatory Engineering Change Control Specialist
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Mahwah, New Jersey, United States iMPact Business Group Full timeJob Title: Regulatory Engineering Change Control SpecialistOur client, a Global Leader in the Medical Device Industry, is seeking a highly skilled Regulatory Engineering Change Control Specialist to join their team. As a key member of the EUMDR project, you will be responsible for ensuring compliance with regulatory requirements and maintaining the highest...
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