Device Registrations

6 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 can only be worked in the UK and not overseas.

Government departments and agencies are working towards implementing a minimum 60% attendance in office sites.

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.

**Who are we?**

The Medicines and Healthcare products Regulatory Agency enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.

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 Authorisation Lifecycle function will realise efficiencies by centralising and automating high volume low complexity tasks. This function will become the enabling engine room, central to delivery of the frontline HQA portfolio.

**What’s** the role?**

**Key responsibili**t**ies**:

- Learn standard operating processes for data processing packages quickly.
- Work collaboratively with other HQA colleagues to ensure all Device Registrations are processed and logged according to standard operating procedures. Seek input from specialist colleagues when required.
- Liaise with manufacturers and other economic operators to guide them where necessary in using unfamiliar MHRA IT processes for Device Registration.
- Ensure the Registration and Accounts mailboxes are managed efficiently, ensuring all enquiries are responded to within set deadlines or redirected where appropriate.

**Who are we looking for?**
- Take responsibility for making effective and fair decisions, in a timely manner and analyse and research further information to support decisions
- Have proven organisational skills and a demonstrable track record working to deadlines in a pressurised, target driven environment, whilst maintaining high standards of quality
- Have a positive and focused attitude to achieving outcomes, despite any setbacks, and regularly check performance against objectives, making suggestions for improvement or taking corrective action where necessary.
- Have good customer service skills, and create clear plans and set priorities which meet the needs of both the customer and the business.

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification

**The selection process**:

- Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.

Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role. Applications are scored based on the competency-based answers provided
- ensure you have read these thoroughly and allow sufficient time. You can view the criteria for this role in the job description.

Closing date: 6th February

Shortlisting dates: 8th and 9th February

Interview dates: 20th and 21st February

Any move to the MHRA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes, including Tax-Free Childcare. Determine your eligibility here.

If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk

Civil Service Commission

Room G/8

1 Horse Guards Road

London

SW1A 2HQ

  • Product Registration Expert

    4 weeks ago

    London, Greater London, United Kingdom Cure Talent Ltd Full time

    A market-leading MedTech manufacturer seeks a seasoned Regulatory Affairs Engineer to strengthen their team. With a focus on innovative surgical products, this company requires an experienced professional to lead product registration efforts and ensure ongoing regulatory compliance.Job Summary:Develop and maintain Technical Files according to MDR...

  • Global Head RA Medical Devices

    2 weeks ago

    London, United Kingdom Novartis Farmacéutica Full time

    The Global Head of RA Medical Devices is responsible for leading the RA Regulatory Device team that is accountable for the development and implementation of the regulatory strategy for all Novartis Medical Devices, medical device components for Combination products, and Software-as-Medical Device. The Global Drug Development therapeutic areas included are:...

  • Global Head RA Medical Devices

    6 days ago

    London, United Kingdom Novartis Farmacéutica Full time

    The Global Head of RA Medical Devices is responsible for leading the RA Regulatory Device team that is accountable for the development and implementation of the regulatory strategy for all Novartis Medical Devices, medical device components for Combination products, and Software-as-Medical Device. The Global Drug Development therapeutic areas included are:...

  • Global Head RA Medical Devices

    1 week ago

    London, United Kingdom Novartis Farmacéutica Full time

    The Global Head of RA Medical Devices is responsible for leading the RA Regulatory Device team that is accountable for the development and implementation of the regulatory strategy for all Novartis Medical Devices, medical device components for Combination products, and Software-as-Medical Device.The Global Drug Development therapeutic areas included are:...

  • Global Head RA Medical Devices

    2 weeks ago

    London, United Kingdom Healthcare Businesswomen’s Association Full time

    Job Description Summary The Global Head of RA Medical Devices is responsible for leading the RA Regulatory Device team that is accountable for the development and implementation of the regulatory strategy for all Novartis Medical Devices, medical device components for Combination products, and Software-as-Medical Device. The Global Drug Development...

  • Global Head RA Medical Devices

    1 week ago

    London, United Kingdom Healthcare Businesswomen’s Association Full time

    Job Description SummaryThe Global Head of RA Medical Devices is responsible for leading the RA Regulatory Device team that is accountable for the development and implementation of the regulatory strategy for all Novartis Medical Devices, medical device components for Combination products, and Software-as-Medical Device.The Global Drug Development therapeutic...

  • Client Device Technical Liaison

    4 days ago

    London, Greater London, United Kingdom Stone Technologies Ltd Full time

    About the RoleAs a Client Device Technical Liaison, you will be responsible for supporting the Strategic Partner Manager for branded client devices, collaborating with sales on opportunity pipelines, and facilitating stock management and deal registrations.The ideal candidate will have experience in digital sales and marketing, IT channel knowledge, and...

  • Head of Device Data Management

    6 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 Compliance Manager

    4 weeks ago

    London, Greater London, United Kingdom Cure Talent Ltd Full time

    Cure Talent Ltd has partnered with a renowned MedTech company to find a top-notch Regulatory Affairs Engineer to support their growth strategy. Based in the home counties, this business excels in developing innovative surgical products and requires an expert in regulatory affairs to oversee product registrations.About the Role:Maintain and develop Technical...

  • Cardiac Physiologist

    6 months ago

    South West London, United Kingdom Bupa Full time

    **Job Title: Cardiac Physiologist - Devices** **Location: Cromwell Hospital, 164-178 Cromwell Road, London SW5 0TU** **Permanent / Contract: Permanent** **Salary range: £55000 -£60000 per annum ( dependent on experience and qualifications)** **Role specific benefits**:Monday to Friday** **Full time/part time: Full-Time, 37.5 hours per week (4 long...

  • Nurse Specialist for Medical Devices

    4 weeks ago

    London, Greater London, United Kingdom MediTalent Ltd Full time

    MediTalent Ltd is seeking a highly motivated and experienced Clinical Sales Nurse to join their team in Bournemouth, England. This exciting opportunity will allow you to leverage your clinical knowledge and sales skills to improve patient outcomes by providing training and support to customers.The successful candidate will work closely with the Commercial...

  • Highly Specialised Cardiac Physiologist

    6 months ago

    London, United Kingdom Bupa Global Full time

    Highly Specialised Cardiac Physiologist - Devices **Job Description**: **Job Title: Highly Specialised Cardiac Physiologist - Devices** **Location: Cromwell Hospital, 164-178 Cromwell Road, London SW5 0TU** **Permanent / Contract: Permanent** **Salary range: Competitive.** **Role specific benefits: Monday to Friday** **Full time/part time: Full-Time,...

  • Medical Devices Project Manager

    4 weeks ago

    London, United Kingdom St George's University Hospitals NHS Foundation Trust Full time

    Job summary We are recruiting a Medical Devices Project Manager, who will be instrumental in the acquisition of medical technology across the Trust. You will be pivotal to our ability to provide safe care to patients, by ensuring that our medical equipment is safe, appropriate, innovative, sustainable and always available. You should have a degree...

  • Highly Specialised Cardiac Physiologist

    2 months ago

    London, United Kingdom Bupa Full time

    Job Description: Job Title: Highly Specialised Cardiac Physiologist - Devices Location: Cromwell Hospital, 164-178 Cromwell Road, London SW5 0TU Permanent / Contract: Permanent Salary range: Competitive. Role specific benefits: Monday to Friday Full time/part time: Full-Time, 37.50 hours per week (4 long shifts per week) Bupa is one of the...

  • Head of Network Management

    2 weeks ago

    London, United Kingdom Healthcare Businesswomen’s Association Full time

    The Global Head of RA Medical Devices is responsible for leading the RA Regulatory Device team that is accountable for the development and implementation of the regulatory strategy for all Novartis Medical Devices, medical device components for Combination products, and Software-as-Medical Device. Ophthalmology, Respiratory/Allergy, Neuroscience,...

  • Regulatory Affairs Director

    22 hours ago

    London, Greater London, United Kingdom Novartis Farmacéutica Full time

    Job DescriptionThe Global Head of RA Medical Devices is responsible for leading the RA Regulatory Device team. This role requires a strong leader who can define an RA Medical Devices vision and strategy to optimize business processes, organizational structure, collaborative culture, and strong learning environment.This position offers hybrid working,...

  • Medical Devices Specialist

    4 weeks ago

    London, Greater London, United Kingdom University College London Hospitals NHS Foundation Trust Full time

    About the OpportunityUCLH is one of the most complex NHS trusts in the UK, serving a large and diverse population. As a Senior Clinical Technologist, you will play a key role in delivering top-quality patient care and excellent education through the development and implementation of clinical systems.Main ResponsibilitiesCollaborate with clinicians,...

  • Regulatory Affairs Specialist

    6 months ago

    London, United Kingdom ConvaTec Full time

    Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services...

  • IVD Compliance Manager

    1 day ago

    London, Greater London, United Kingdom Cpl Life Sciences Full time

    Cpl Life Sciences is seeking a highly skilled IVD Compliance Manager to join our team. In this role, you will be responsible for managing product licence registration with worldwide regulatory authorities.Main responsibilities:Preparing and compiling regulatory documentation, coordinating and executing regulatory submissions in compliance with ISO13485, IVD...

  • Clinical Research Data Specialist II

    3 weeks ago

    London, Greater London, United Kingdom Lifelancer Full time

    Job Title: Clinical Research Data Specialist IIAbout the Role:We are seeking a skilled Clinical Research Data Specialist II to join our team at ICON plc. As a key member of our clinical research operations, you will play a crucial role in ensuring the quality and integrity of our data.About Us:ICON plc is a world-leading healthcare intelligence and clinical...