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Devices Regulatory Specialist
2 months ago
**Details**:
**Reference number**:
- 286263**Salary**:
- £54,088**Job grade**:
- Grade 7**Contract type**:
- Fixed Term
- Loan
- Secondment**Length of employment**:
- 12 months**Business area**:
- MHRA - Healthcare, Quality and Access Group**Type of role**:
- Medical
- Science**Working pattern**:
- Full-time**Number of jobs available**:
- 1Contents
Location
About the job
**Benefits**:
Things you need to know
Location
- Canary Wharf, LondonAbout the job
**Job summary**:
Medicines and Healthcare products Regulatory Agency (MHRA) are hiring
We are seeking an organized **Devices Regulatory Specialist** to join our** Innovative Devices** Function in the **Healthcare Quality & Access **Group. This is a** full-** **time** opportunity on a **fixed-term/loan/secondment basis** for 12 months.**
The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU. Please be aware that this role can only be worked in the UK and not overseas. We are currently implementing a flexible, hybrid way of working, with a minimum of 4 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 8 days a month, with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment.
To find out more information about MHRA and the exciting opportunities on offer click here and explore your future career at MHRA.
**Who are we?**
The MHRA is transforming, creating a progressive, responsive and sovereign regulator of medical products that is a fundamental requirement to achieve the innovation set out in the UK Life Sciences Vision.
The objective of the Healthcare Quality and Access portfolio is to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated access pathways. It will do this by bringing together a fusion of our capabilities across both medicines and medical devices to enable licensing and market access, as well as ensuring compliance with regulations and standards.
The Innovative Devices function works to provide pre-market support and facilitates a smooth passage to market access. This is particularly aimed at innovative products across med-tech, diagnostics and digital, or where there is higher associated risk. The function will ensure that the UK has supply of new and advancing medical devices to include software as a medical device, novel implantables and diagnostics and play a significant role in developing the new Regulatory Framework for Medical Devices.
**Job description**:
This role is an exciting opportunity to support a Wellcome Trust funded project to ensure that digital mental health products are regulated in a risk proportionate manner and evaluated consistently so users have access to safe and effective products, which could help improve mental health care significantly.
The post holder will contribute to the development and implementation of mental health medical device software regulation and guidance and will undertake significant engagement and partnership work with key senior external stakeholders, government departments, professional bodies and the wider health sector to ensure UK patients have access to safe and effective mental health medical device software.
**Key responsibilities**:
- Support a significant work programme to increase focus on the importance of safer and effective mental health software medical devices
- Provide regulatory capacity to inform regulatory decision making
- Develop effective external partnerships with key external stakeholders especially partners in the Wellcome funded project such as NICE, mental health charities, and industry
- Work across Innovative Devices and the wider Agency to develop policy related to mental health and coordinate on mental health medical devices
**Person specification**:
**Benefits**:
- Annual Leave: 25 days annual leave on entry, rising by one day for each completed year of service to a maximum of 30 days and pro-rata for part-time staff. PLUS 8 bank holidays
- Privilege Leave: 1 day
- Hours of Work: 37 hours (net) per week for full time staff in all geographical locations, including London and pro rata for part-time staff
- Occupational Sick Pay (OSP): One month full pay/one month half pay on entry, rising by one month for each completed year of service to a maximum of five months full pay/five months half pay
- Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil Service
- Flexible working to ensure staff maintain a healthy work-life balance
- Interest free season ticket loan or bike loan
- Employee Assistance Services and access to the Civil S
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