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Quality And Regulatory Affairs Associate

Company: White Rose Recruitment Limited    Location: Leeds

Job Summary

About the Company

Trading in Leeds since 1974, our client is a specialist manufacturers of silicone tubing and surgical devices used in operating theatres. They supply products to the N.H.S., distributors and private hospitals around the U.K. as well as exporting to many organisations worldwide.

Many of their products have been designed in response to requests from leading surgeons and operating theatre personnel and include drains and tubing, ear, nose and throat products, general surgical equipment, and laser protection, which are mainly manufacture, and hand finished from their premises in Leeds.

About the role

The Quality and Regulatory Affairs Associate will ensure compliance with the legal requirements for all medical devices regulations, CE marking, licensed product design for manufacture and sale, and for the QMS and Technical Files.

The jobholder will have a good first degree in a relevant scientific discipline and ideally, relevant experience in regulatory affairs or quality in a medical devices industry. Equally important, the jobholder must have a working knowledge of quality standards ISO 9001, ISO 13485, the Medical Device Directive (MDD 93/42/EEC) and possess computer competency in Microsoft office software, data collection and general analysis tools.

Key accountabilities

Quality

  • To maintain the Quality Management System (QMS) and put forward for approval any amendments or improvements that are identified;
  • To monitor and ensure that the requirements of the Quality Manual are implemented throughout the Company;
  • To carry out Internal Quality Audits and to provide performance reports on the effectiveness of the Quality System as a basis for monitoring improvements. This is to be done in consultation with the Quality Engineer and the Management team;
  • To assist in the investigation of all customer complaints with the Customer Services Team and CEO;
  • Maintain the customer complaints files;
  • Carry out calibration functions, such as calibration of plug gauges, and entry of relevant information in the calibration register (monthly / yearly);

Regulation

  • Define data and information needed for regulatory approvals;
  • Develop labelling specifications and approve proposed labelling, packaging, advertising and promotional materials after evaluating conformance to applicable regulations;
  • Provide advice on packaging and labelling requirements, ensuring compliance with the directives;
  • Provide regulatory affairs support during internal and external audits in line with Notified Body requirements;
  • Plan schedules for regulatory deliverables on a project and monitor projects through to completion;
  • Assist in the development of best practices for Regulatory Affairs processes;
  • Represent Regulatory Affairs on cross-functional project teams;
  • Liaise with the relevant authorities with regards to product manufacture and compliance with Medical Devices Directive;
  • Maintain all policies in line with Medical Devices Directive and other applicable standards;
  • Establish and maintain the CE documentation to ensure that the products manufactured meet with the legislations in force;
  • Administer the registration of CE devices manufactured or sold by us;
  • Liaise with the relevant authorities regarding product manufacture and compliance with Medical Devices Directive, and licensed product requirements;
  • Participate in new product development ensuring compliance with relevant regulatory bodies;
  • Conduct annual reviews on Product Technical Files to ensure compliance with the harmonised standards, Medical Device Directive and other applicable standards;
  • Monitor, review and update the Clinical Evaluations and Risk Assessments as defined in the procedures for every product;
  • Monitor, review and update any processes and documents required with changes to applicable harmonised standards, Medical Device Directive and other applicable standards;
  • Conduct Post Market Surveillance Reviews in line with the regulations and companys procedures for all products;
  • Ensure compliance requirements are established and met for all countries of sale
  • Observe Health & Safety requirements;
  • Other duties as required.

Job Type: Full-time

Required experience:

  • medical devises Regulatory Affairs: 1 year