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Medical Device Regulatory Expert

1 month ago

Didcot, Oxfordshire, United Kingdom ResMed Full time
The ResMed company is looking for a skilled QA Engineer to join their Quality Assurance team. The successful candidate will have experience with ISO 13485 Medical Standard and knowledge of EU MDR 2017/745 & local regulations.

In this role, you will be responsible for managing quality activities/actions within the framework of the processes constituting the Quality Management Systems in EMEA, contributing to establishing and maintaining metrics and feedback mechanisms to monitor continued effectiveness of QMS in EMEA, conducting quality audits of suppliers and service providers, and supporting the response to audit findings and CAPAs in EMEA.

An estimated salary of $80,000 - $110,000 per annum is offered, along with various benefits such as flexible working hours, bonus plans, and access to preferred shareholding programs.

  • Support to ensure all aspects of the ResMed EMEA Quality Management Systems (QMS) are compliant and aligned with: Applicable regulatory standards/requirementsBusiness requirements As well as other ResMed QMS entities when applicable.
  • Manage quality activities/actions within the framework of the processes constituting the Quality Management Systems in EMEA (as applicable): Ensure the implementation of the actions, procedures, and processes necessary for the compliance of the Quality activities with the ResMed quality policy and the European (or UK) regulations in force, to achieve quality objectives. Proactively contribute to reviewing, analysing, and implementing opportunities for continual improvement of the QMS, quality documents and records in EMEAs Reporting to management any obstacles or potential hazards, that may impact the effectiveness of the quality management system; and identify any need for improvement.
  • Contribute to establishing and maintaining metrics and feedback mechanisms to monitor continued effectiveness of QMS in EMEA to business and regulatory needs. Ensure effective communication with relevant parties.
Responsibilities

This role involves creating and building relationships with medical device regulatory in every country, managing quality activities/actions within the framework of the processes constituting the Quality Management Systems in EMEA, and promoting a culture of quality through continuing education, consultation, and contributing to management review.

You will also contribute to establishing and maintaining metrics and feedback mechanisms to monitor continued effectiveness of QMS in EMEA, support global quality projects required for implementation in EMEA, conduct quality audits of suppliers and service providers, and support the response to audit findings and CAPAs in EMEA.

  • Support to ensure all aspects of the ResMed EMEA Quality Management Systems (QMS) are compliant and aligned with: Applicable regulatory standards/requirementsBusiness requirements As well as other ResMed QMS entities when applicable.
  • Manage quality activities/actions within the framework of the processes constituting the Quality Management Systems in EMEA (as applicable): Ensure the implementation of the actions, procedures, and processes necessary for the compliance of the Quality activities with the ResMed quality policy and the European (or UK) regulations in force, to achieve quality objectives. Proactively contribute to reviewing, analysing, and implementing opportunities for continual improvement of the QMS, quality documents and records in EMEAs Reporting to management any obstacles or potential hazards, that may impact the effectiveness of the quality management system; and identify any need for improvement.
  • Contribute to establishing and maintaining metrics and feedback mechanisms to monitor continued effectiveness of QMS in EMEA to business and regulatory needs. Ensure effective communication with relevant parties.
Benefits Package

The ResMed company offers a competitive salary package, with an estimated annual salary of $80,000 - $110,000, flexible working hours, bonus plans, and access to preferred shareholding programs.