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.
Qualifications
— 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.
— Good communication skills.
— Excellent technical writing.
— At least the Upper-Intermediate English level.
Preferred skills
— 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.
We offer
— Opportunities to work with the industry-leading partners and customers;
— Friendly experienced colleagues and perfect work equipment;
— Opportunities for career growth and raising professional skills;
— Visiting position related conferences and courses for self-improvement;
— Comfortable offices in the city center;
— Lunches, snacks, and hot drinks available;
— English courses;
— Travel opportunities;
— Decent salary, tax assistanc.
ABCloudZ is looking for a Regulatory Affairs/Quality Assurance Еngineer who will ensure continual visibility over the development and in-built references of legal and regulatory enactments. Also, you’ll identify activities necessary to ensure compliance. Besides, the candidate will ensure that the product team establishes controls and/or completes necessary activities to provide compliance.
Further, at ABCloudZ, the Regulatory Affairs/Quality Assurance Еngineer will conduct reviews to ensure knowledge and fulfillment of device licensing, surveillance and corrective action reporting, translation, product standards, and all other requirements necessary to support import, sales, distribution, installation, and support in all chosen distribution markets.