Exciting Medical Devices Development company seeks a highly self-motivated and enthusiastic RA Officer.
About the role:
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.
Duties may include:
- Manage individual projects and work packages as required.
- Assist with the compilation and maintenance of compliant medical devices files for all 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.
- 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.
- 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.
Skills and experience:
- 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.
- Be eligible to work full time in the UK without restriction.