Position: Regulatory Affairs / Quality Assurance Еngineer
Company: ABCloudZ
Category: QA
Experience required: 1y
English level: upper

**Required skills**
— 1+ years of experience in a position responsible for medical device quality engineering duties. 
— QA Engineer technical background 
— Ability to manage multiple projects at once.
— At least the Upper-Intermediate English level.
— Good communication skills.
— Excellent technical writing.

**Will be a plus**
— Experience with quality systems regulations, ISO standards, information privacy and security, environmental controls.
— Expertise working in a regulated environment as a QA/BA.
— Practice working with medical device development.

**Responsibilities**
— Remain aware of new or updated regulations, standards, and other official enactments that may apply to the product.
— Provide detailed analysis and gap analyses for new or revised enactments, SOPs.
— Ensure compliance schemes associated with all regulatory compliance documents distributed during the development.
— Participate in cross-functional design review teams to review all product improvement Design Inputs and potential Defect Reports. 
— Recognize potential impacts on health or device efficacy (Safety Issues), criticality assessment to ensure the application of reasonable and required Risk Management, Verification, and Validation.