Regulatory Documentation Specialist

1 week ago


Boston, Massachusetts, United States RQMIS Inc Full time
Job Overview

RQMIS Inc, a leading medical device/biotechnology consultancy, is seeking an experienced Regulatory Documentation Specialist to join our team in Amesbury, MA. As a key member of our team, you will play a crucial role in supporting projects involving labeling, regulatory submissions, quality system documentation, and clinical study material.

Key Responsibilities
  • Provide overall management of technical writing projects, assigned by the Sr. Technical Writer, for clients' needs in areas of design, creation, and maintenance of technical documentation.
  • Support Client and/or RQMIS change control and quality records procedures, ensuring compliance with applicable Quality Management System (QMS), standards, and regulations.
  • Develop and publish regulatory submissions: 510(k), IDE, PMA, etc.
  • Create and edit Quality System documentation (SOPs, Flowcharts, and so on).
  • Maintain electronic tools (including cloud-based) to maintain QMS of RQMIS/Client.
Requirements

To succeed in this role, you will need:

  • Bachelor's degree in engineering or technical field (biomedical, mechanical, chemical, electrical, biochemical engineer, chemist, microbiologist, etc.).
  • 1-3 years of experience with medical device regulations/standards (including domestic and international markets).
  • Experience creating technical documentation.
  • Strong attention to detail.
  • Strong computer skills, including Word, Excel, SharePoint, OneDrive, Visio, and Adobe Professional.
Work Environment

You will work in a fast-paced, dynamic environment with a collaborative team. Our office is located in the north of Boston Massachusetts area, and we offer a competitive salary.

The estimated annual salary for this position is $ 90,000.

This is a full-time employment opportunity with regular working hours and occasional travel (less than 10%). We offer excellent opportunities for professional growth and development.



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