Regulatory Affairs Officer
6th October 2021 | Thomas Goepfert
Regulatory Affairs Officer
The Regulatory Affairs Officer is responsible for helping to ensure that QuantuMDx products comply with regulations in all registered territories.
The RA Officer will help to compile regulatory submissions relating to QuantuMDx products, maintain compliant medical device files and support the compliant development of future QuantuMDx products. The Regulatory Affairs Officer will also be involved in the improvement and support of the company’s Quality Management System alongside the QRA team by identifying potential improvements and efficiencies and helping to develop, revise and implement company procedures and policies.
The Regulatory Affairs 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
Performing a combination, but not necessarily all, of the following duties:
- 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
- Assist with the compilation and maintenance of compliant medical devices files for all QuantuMDx products.
- Assist with compilation and maintenance of compliant technical files, summaries, and indices.
- Prepare and maintain product requirement trace matrices using Aligned Elements software.
- Ensure technical and scientific data is collected and reported in line with relevant regulatory requirements.
- Help to prepare submission dossiers and support the authoring of sound technical arguments and explanations to support product licensing.
- Supporting the timely registration of current and new products with the correct regulatory authorities.
- Support review of product labelling and documentation for compliance with global requirements.
- Support post-market data gathering and reporting in line with regulatory requirements and company Post Market Surveillance and Vigilance procedures.
- Maintain a proactive awareness of relevant Regulatory updates including contributing to assessment for impact on the company’s QMS.
- Effectively interact with and advise Technical and Development teams to ensure research and development is carried out in line with regulatory requirements as needed.
- Participate in 3rd party audits of QuantuMDx.
- Support the administration of a company-wide risk-based comprehensive training system.
- Help to design and deliver training sessions to ensure the understanding and compliance of all employees.
- Take an active role in compliant software development and compliance review.
- Support design review and control of change processes.
- Promote the benefits of the quality system to all employees.
- Work within the rest of the QRA team to maintain focused, effective progression in line with Company Quality objectives.
- Support the QRA team by attending and providing feedback on training and mentoring activities.
- Perform other duties that may be required from time to time.
- Ability to manage multiple conflicting activities to deliver on time.
- Be receptive to delegated priorities and direct their own activities whilst supporting the team’s activities.
- Identify risks to delivery, look for mitigating actions and inform line and senior management
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.
- Good sense of humour and ability to adapt to a changing environment.
- Be eligible to work full time in the UK without restriction.
QuantuMDx is a UK-based developer of transformational point-of-care diagnostics, with global operations.
QuantuMDx has developed Q-POC™ – a rapid, portable, PCR point of care diagnostic system. Q-POC™ compresses an entire molecular diagnostic laboratory into a simple to use, accessible and affordable single device, for use at the point of care, with results in approximately 30 minutes. Q-POC™ has been designed for front-line healthcare professionals within a wide range of settings, including emergency rooms, ICU and birthing centres, clinics and pharmacies. Patients are tested, diagnosed and given treatment options in one efficient consultation.
Our first Q-POC™ test detects SARS-CoV-2, the virus causing COVID-19.
To apply for this role, please complete the form below and attach your CV. Thank you.
The intent of this job description is to provide a representation and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
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