Quality Assurance & Regulatory Affairs Consultant

Location: Boston, Massachusetts Salary: competitive
Sector: Medical Devices, Quality Assurance (QA), Regulatory Affairs (RA) Type: Contract

I am partnering an exciting Medical Device company based just south of Boston, MA to secure a Quality Assurance & Regulatory Affairs Consultant on a 6 month temp-to-hire basis.

This company are a well respected business and both develop and manufacture their own brand products as well as OEM for some of the globally leading Medical Device organizations and sell their products globally.The successful Quality Assurance & Regulatory Affairs Consultant will have complete ownership of the Quality system and manage their growing number of suppliers as well as the Regulatory affairs department.

Key Responsibilities:

  • Improve and maintain the Quality Management System
  • Secure their ISO 13485:2016 certification
  • Manage and audit their suppliers and customers
  • Responsible for creation and maintenance of technical files

Key Skills & Experience Required:

  • At least 5 years of Quality & Regulatory experience in a Medical Device Manufacturing environment
  • In-depth knowledge of international Medical Device regulations and standards including ISO 13485 and 21 CFR 820
  • Ability to work independently

If this is of interest, apply now!

Phone Interviews are happening Tuesday 7th August and the final stage on-site will be on Thursday 9th or Friday 10th August.

Sthree US is acting as an Employment Business in relation to this vacancy.