Company Description

Come join us and make a difference in the world! 

Discover more at www.necsws.com 

Job Description

DCB0129 (Clinical Risk Management: its Application in the Manufacture of Health IT Systems) and ISO 13485 (Medical Devices) are becoming increasingly relevant standards to our organisation with many of our products requiring clinical input during the design and development phases of the product lifecycle. 

The Clinical Administrator will be the person responsible for ensuring that our clinical risk processes are embedded across the NECSWS product range in both our screening and registries areas during product development. 

The clinical administrator will be responsible for ensuring that clinical risk processes we have in place are robust, adhere to the standards above and are followed properly for each product release. For products that do not currently follow the clinical risk process, the clinical administrator will also be responsible for embedding the process. 

Key Responsibilities 

• Ensure that clinical risks in a live environment are documented and communicated to key stakeholders. 

• Ensure that clinical risk is considered and documented during product design. 

• Work with each of the product owners to ensure that Clinical Risk meetings are booked with appropriate stakeholders. 

• Prepare for and chair Clinical Risk meetings. 

• Ensure that the clinical risk process and clinical risk plans for each product are kept up to date on an annual basis. 

• Ensure that the Clinical Safety Case Report is completed by Clinical Consultants for each product release 

• Keep all hazard logs up to date 

• Work to embed clinical risk processes into teams that currently have none. 

• Work with the teams in relevant departments to ensure they meet the compliance criteria for ISO13485. 

• Contribute to Requests For Information (RFIs) and tender documents to highlight our clinical risk processes. 

Qualifications

Required skills / Knowledge 

• Experience working in an administration environment 

• Ability to co-ordinate groups of people 

• Ability to chair meetings effectively 

• Ability to make effective use of Microsoft Word and Microsoft Excel 

• Knowledge of Microsoft SharePoint 

Additional skills / Knowledge 

• Experience working in a clinical environment 

• Knowledge of Azure DevOps 

• Have attended the NHS Digital Clinical Safety Training 

• Knowledge of ISO13485 

Additional Information

We pride ourselves in offering an excellent benefits package, including an above average pension scheme. When you join the team at NEC Software Solutions, you are provided with the following: 

• Private Medical Cover funded by NEC for Employees (with the option to add family members at an additional cost)  
• 25 days paid holiday with the option to buy/sell  
• 4 x basic salary life assurance cover funded by NEC (with the option to increase cover at an additional cost) 
• A Group Pension Plan with fantastic employer contributions up to a maximum of 8.5% 
• A selection of flexible benefits to suit your individual needs  

Candidates must be able to demonstrate a pre-existing right to work and travel within the UK. Documentary evidence will be required. 

All offers are subject to satisfactory vetting and reference checks.  

Who we are?

NEC Software Solutions is an equal opportunities employer, welcoming applications from all communities. 

We’re NEC Software Solutions (part of global tech giant NEC Corporation). While you read this ad, our software is helping to dispatch ambulances, support families, keep trains on the move, locate missing people and even test the hearing of newborn babies. 

Working with us, you’ll be helping our 3,000+ employees push the boundaries of what’s possible and support amazing public services. 

We work with governments, hospitals, police forces, housing providers, local authorities and more. We help them pay financial support faster, speed up treatments for patients and respond to emergencies in the right way. The more we do, the more our customers can do for others. And together, we make a world of difference. 

We’d love your help. And we’ll support you all the way.