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Regulatory Affairs Quality Assurance Engineer

Billerica, MA 01821 | Contract

Job ID: 49324 Industry: Engineering

Our client, located in Northern Massachusetts, is looking for an experienced Regulatory Affairs Quality Assurance Engineer.

Job Overview:

You would  provide support for new product development and transform the on-market product development documentation in alignment with the latest regulatory requirements. Focus on improvement of the technical files and risk management documentation including reviewing product and manufacturing process changes, supplier changes, new and revised engineering protocols and reports, and reviewing product labeling. Ensure compliance with the design control process and with the Quality Management System. The position will work closely with the Research and Development Engineering group as well as QA/RA.

Skills and Experience Required:

Must possess knowledge of domestic (FDA) and foreign regulatory requirements for the manufacture and distribution of medical devices (especially design control and technical file compilation). Must have working knowledge of Microsoft Windows software; Word, Excel, Access and PowerPoint. Must be able to meet deadlines, prioritize work, take the initiative to follow-up on outstanding issues, complete assigned tasks, handle multiple tasks, and work independently. Able to communicate effectively (verbal and written) with internal and external customers, and third-party registrar.

BS or BE in a relevant science or engineering discipline with 3-5 years’ experience in regulated industry.

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