Devices Regulatory Specialist

2 months ago

London, United Kingdom Medicines and Healthcare Products Regulatory Agency Full time

**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

  • Devices Regulatory Lead

    3 months ago

    London, United Kingdom Medicines and Healthcare products Regulatory Agency Full time

    We are currently looking for a **Devices Regulatory Lead **to join our **Software and AI** **Team within the **Healthcare Quality and Access** **group. This is a **full-time** opportunity, on a **12** month** fixed term contract/internal move or temporary promotion **basis. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU. Please...

  • Regulatory Borderline Specialist

    2 weeks ago

    London, Greater London, United Kingdom Medicines and Healthcare Products Regulatory Agency Full time

    Position OverviewThe Medicines and Healthcare Products Regulatory Agency is in search of a Regulatory Borderline Specialist to contribute to the Authorisation Lifecycle subgroup within the Healthcare Quality & Access division.This is a full-time role on a 12-month Fixed Term basis, primarily located in London. Please note that this position is restricted to...

  • Regulatory Borderline Specialist

    2 weeks ago

    London, Greater London, United Kingdom Medicines and Healthcare Products Regulatory Agency Full time

    Position OverviewThe Medicines and Healthcare Products Regulatory Agency is looking for a Regulatory Borderline Specialist to be part of the Authorisation Lifecycle subgroup within the Healthcare Quality & Access division.This is a full-time position on a 12-month Fixed Term contract, primarily based in London. Please note that this role is exclusively...

  • Head of Device Data Management

    3 months ago

    London, United Kingdom Medicines and Healthcare products Regulatory Agency Full time

    We are currently looking for a **Head of Device Data Management** to join our **Scientific Data and Insight** team** within the **Safety and Surveillance Group** group. This is a **full-time **opportunity, on a **permanent basis**. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU. Please be aware that this role can only be worked...

  • Medical Device Regulatory Affairs Lead

    2 months ago

    London, United Kingdom Parexel Full time

    When our values align, there's no limit to what we can achieve.   We are looking for a Regulatory Affairs Consultant - Medical Device Regulatory Lead for Alliance Combination Products will oversee key regulatory activities and report to the Global Device Regulatory Head for Alliance Combination Products, who in turn reports to the Head of GRA...

  • Sds Author

    3 months ago

    London, United Kingdom VRS Regulatory Full time

    We are looking for a Safety Data Sheet / SDS Author / Regulatory Officer for a London based consumer products company. Your role will be varied and include researching pending changes developments to global chemical regulations, developing regulatory documents (SDSs, labels etc) for new and existing products, and providing regulatory support to internal...

  • Regulatory Affairs Lead

    2 weeks ago

    London, Greater London, United Kingdom Medicines and Healthcare Products Regulatory Agency Full time

    Job OverviewThe Medicines and Healthcare Products Regulatory Agency is looking for a Borderline Lead to be part of the Authorisation Lifecycle subgroup within the Healthcare Quality & Access division.This is a full-time position on a 12-month Fixed Term contract, primarily based in London. Please note that this role is designated for UK-based candidates...

  • Associate Director, Regulatory Affairs

    3 weeks ago

    London, United Kingdom Cpl Healthcare Full time

    Job Title: Associate Director, Regulatory Affairs - Medical Devices Job Type: Full Time, Permanent Position Location: Greater London, UK and some EU locations Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology....

  • Associate Director, Regulatory Affairs

    3 weeks ago

    London, United Kingdom Cpl Healthcare Full time

    Job Title: Associate Director, Regulatory Affairs - Medical Devices Job Type: Full Time, Permanent Position Location: Greater London, UK and some EU locations Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology....

  • Associate Director, Regulatory Affairs

    2 months ago

    London, United Kingdom Cpl Healthcare Full time

    Job Title: Associate Director, Regulatory Affairs - Medical DevicesJob Type: Full Time, Permanent PositionLocation: Greater London, UK and some EU locationsRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due to...

  • Associate Director, Regulatory Affairs

    2 months ago

    London, United Kingdom Cpl Full time

    Job Title: Associate Director,  Regulatory Affairs -  Medical DevicesJob Type: Full Time, Permanent Position Location: Greater London, UK and some EU locations Remuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specialises in Cancer and Supportive Care, Gastroenterology and Hepatology. Due...

  • Associate Director, Regulatory Affairs

    4 weeks ago

    Greater London, United Kingdom Cpl Life Sciences Full time

    Job Title: Associate Director, Regulatory Affairs - Medical DevicesJob Type: Full Time, Permanent PositionLocation: Greater London, UK and some EU locationsRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specialises in Cancer and Supportive Care, Gastroenterology and Hepatology. Due to...

  • Senior Quality and Regulatory Specialist OR Engineer – Medical Devices

    1 month ago

    London, United Kingdom King's College London Full time

    About us We are seeking experts in medical device design regulatory processes to join our team and work with project groups to translate novel technologies to the clinic. We welcome applications from individuals with experience in: Software as a Medical Device Design Controls IEC 60601 Regulatory Affairs supporting MedTech start-up organisations Quality...

  • Senior Quality and Regulatory Specialist OR Engineer – Medical Devices

    4 weeks ago

    London, Greater London, United Kingdom King's College London Full time

    About usWe are seeking experts in medical device design regulatory processes to join our team and work with project groups to translate novel technologies to the clinic.We welcome applications from individuals with experience in:Software as a Medical DeviceDesign ControlsIEC 60601Regulatory Affairs supporting MedTech start-up organisationsQuality Management...

  • Lead Regulatory Affairs Specialist

    2 weeks ago

    London, Greater London, United Kingdom MSI Group Ltd Full time

    MSI Group Ltd is on the lookout for an accomplished Regulatory Affairs Specialist in the medical devices sector to enhance their distinguished Consumer Healthcare division with a flexible working arrangement.Key Responsibilities:Formulate regulatory pathways for both EMEA and international markets.Provide regulatory guidance to product development...

  • Regulatory Affairs Lead

    15 hours ago

    London, Greater London, United Kingdom Austin Vita Full time

    Senior Regulatory Affairs SpecialistAustin Vita seeks a highly skilled Senior Regulatory Affairs Specialist to lead our Regulatory Affairs Team.Ensure medical device regulatory compliance with national and international legislation for projects, products, and new market clearance.Manage specific regulatory objectives to meet the company's Strategic Plan and...

  • Technical Training Specialist

    3 days ago

    London, Greater London, United Kingdom SGS Full time

    Job DescriptionRole Summary:The Technical Training Specialist will be a key member of our team at SGS, responsible for designing, developing, and delivering specialized training programs for our Notified Body, which delivers CE certification services for in-vitro diagnostic medical devices.Key Responsibilities:Training Course Preparation: Support the...

  • Device Registrations

    3 months ago

    London, United Kingdom Medicines and Healthcare products Regulatory Agency Full time

    We are currently looking for a **Device Registrations & Certificate (CFS) Coordinator **to join our **Authorisation Lifecycle** **Team within the **Healthcare Quality & Access** group. This is a **full-time **opportunity, on a **permanent** basis. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU. Please be aware that this role...

  • IT Specialist

    3 months ago

    London, United Kingdom Chelsea and Westminster Hospital NHS Foundation Trust Full time

    The IT Specialist (Medical Devices) is responsible for the audit, identification and integration of Medical Devices where there is a requirement to connect them onto the Trusts data network. The main responsibility of the post holder is to act as a lead for the IT Team liaising with Clinical Engineering Teams, Suppliers and System Admins. Leading in...

  • Mental Health Mission Regulatory and Reimbursement

    5 months ago

    London, United Kingdom Medicines and Healthcare Products Regulatory Agency Full time

    Provide regulatory leadership on the Mental Health Missions operational team, working with Agency partners to accelerate the development of new regulatory and evaluation approaches. - Convene discussions with stakeholders across the system including Mental Health medical product innovators and the regulator and evaluator community to develop relationships,...