Open Position – Design Quality Engineer, Remote

Design Engineer The Design Quality Engineer shall provide support to new product development projects.  Serve as a subject matter expert on the requirements and processes for product lifecycle management. Duties and Responsibilities (Key Deliverables): 1. Ensures that product development projects and changes to current products are conducted in compliance with the FDA Quality System Regulation…

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Open Position – RA Specialist, Remote

The Solheim Group is actively recruiting for permanent Regulatory Specialists for a Medical Device Orthopedics company.The Senior Lifecycle Regulatory Specialist provides regulatory support of the Lifecycle (Postmarket) projects of commercialized products. Accountabilities include activities such as assessment of proposed changes for regulatory impact, regulatory strategy and support for change projects, compliance with Conditions of Approval,…

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