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RA Officer

Job LocationNewcastle Upon Tyne
EducationNot Mentioned
Salary28,000 - 35,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

We are currently recruiting for a Regulatory Affairs Specialist to join our client in the Medical Device sector on a full-time permanent basis in Newcastle. This role can pay a top role salary of £35,000 DOE.The RA Officer is responsible for helping to ensure the companys products comply with regulations in all registered territories. The RA Officer will help to compile regulatory submissions relating to products, maintain compliant medical device files andsupport the compliant development of future products. The RA Officer will also be involved in the improvement and support of the companys Quality Management System alongside the QRA team by identifying potential improvements and efficiencies and helping todevelop, revise and implement company procedures and policies.The RA Officer will work with the QRA team to ensure products and design and development of future products are compliant with the requirements of relevant global regulatory requirements including, but not limited to IVDR, REACH (UK & EU), CLP (UK & EU)with experience of ISO 13485 and ISO 14971 and ideally familiarity with IEC 62304.Key Roles & Responsibilities:

  • Maintain a positive attitude and assist the RA Manager to ensure deliverables are achieved within target timelines.
  • Champion the highest level of quality & process and undertake training in order to develop.
  • Work with the RA Manager to identify and implement process improvements and efficiencies.
  • Manage individual projects and work packages as required.
  • Communicate effectively with all teams and functions within QuantuMDx
Experience, knowledge and requirements:
  • A highly motivated, organized, proactive and enthusiastic individual with a proven ability to work and motivate with utmost tact and diplomacy.
  • A minimum of 2 years experience in medical devices under an ISO 13485 compliant Quality Management System is essential.
  • Experience of IVD medical device regulations including IVDD/IVDR, US FDA, MDSAP.
  • Outstanding teamwork and ability to interact with external and internal partners on fast-paced projects.
If you are interested, please apply and we can get in touch for a call to discuss in detail.SThree are committed to ensuring equal opportunities, fairness of treatment, dignity, work-life balance and the elimination of all forms of discrimination in the workplace for all staff and job applicants.

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