QUALITY MANAGEMENT & REGULATORY AFFAIRS OFFICER
By Gordon Barker on 3rd January 2018
QUALITY MANAGEMENT & REGULATORY AFFAIRS OFFICER
LOCATION: Incubator Building, Grafton Street, Manchester, M13 9XX, UK
APPLICATION DEADLINE: 12th February 2018
ABOUT THE COMPANY
Microbiosensor is a central Manchester based Medical Devices company developing disposable point-of-care diagnostics for microbial infections. Our strategy is to develop simple disposable devices that target high-value market niches, where there is a clear unmet need for improved infection control. The nearest to market application for this technology is an in vitro diagnostic (IVD) for renal dialysis patients. The company anticipates filing a CE mark to permit EU sales for this device in Q2 2019. Other applications for the technology in diagnosing the antibiotic sensitivities of urinary tract and wound care infections are at the laboratory prototype stage.
Microbiosensor is now looking to recruit a Quality Management Systems (QMS) / Regulatory Affairs (RA) officer to the team, to help the company develop its quality management system, product technical files, and the planning and submission of documentation to UK, European and US regulatory authorities.
We are looking for a self-motivated and goal-oriented individual who will help guide the company to its first product launch. The successful candidate must be comfortable in an SME environment and the particular challenges and responsibilities of working within a small, dedicated team. This opportunity might suit an experienced candidate who would welcome both the freedom and responsibility which comes with working in a SME but equally someone with only a few years experience who is looking for new challenges and could fulfill the role with support from external consultants.
Microbiosensor offers a competitive remuneration package, with the potential for share options. The post is available immediately as a full-time position although this could be flexible for the right candidate. Applicants should send their curriculum vitae with a covering letter (including a brief description of experience) to: email@example.com
The names and contact details of two referees will be sought if candidates are selected for final interview.
ESSENTIAL EXPERIENCE / SKILLS
• Experience of technical file preparation for CE-mark submission.
• Experience of quality management systems (QMS) and regulatory affairs (RA) within the Medical Device / IVD industry,
• Knowledge of ISO13485 quality systems.
• Involvement with successful IVD or medical device applications to the MHRA / EMA.
• A strong scientific and /or engineering background.
• Ability and flexibility to balance multiple tasks, meet priorities and deliver within timelines.
• Strong communication skills, both oral and written.
• Ability to work independently and in small multi-disciplinary teams.
• Attention to detail and an enthusiastic, inquisitive, hard-working attitude.
• planning and implementing a QMS.
• Interactions with Notified Bodies.
• Personally authored Technical Files and Design Dossiers.
• Compliance with Essential Requirements and Conformity Route Requirements.
• Knowledge of EMA, FDA or other global device registration authorities.
• Knowledge and experience of QA auditing including accreditation for clean rooms/manufacturing.
• Report directly to the Product Development Director.
• Responsibility for advising on and preparing company QMS and regulatory documents.
• Support the development of colleagues and provide advice on the implementation of quality management procedures and processes.
• Maintain awareness of the regulatory environment and help ensure the company continues to comply with regulatory standards going forward.
Microbiosensor wins Bionow Investment Deal of the Year Award
By Gordon Barker on 13th December 2017
Microbiosensor is pleased to announce that it won the ‘Bionow Investment Deal of the Year Award’ (Sponsored by QIAGEN) in this year’s Bionow Awards. Now in their 16th year, the prestigious awards recognise excellence, outstanding achievement and enterprise in a sector that is worth £11bn to the North’s economy and are sponsored by Manchester Science Partnerships, Appleyard Lees and World Courier. The awards ceremony and gala dinner held on 30th November was attended by more than 400 people at The Mere Golf Resort & Spa in Knutsford, Cheshire.
Microbiosensor secured the ‘Bionow Investment Deal of the Year Award’ for its £1.4m investment deal recently completed with the Northern Powerhouse Investment Fund (NPIF), and the Greater Manchester and Cheshire Life Sciences Fund made through private equity firms Maven Capital Partners and Catapult Ventures respectively.
Company chairman Curtis Dobson comments: “We were absolutely delighted to receive this prestigious award, which reflects the hard work of all those involved in completing this crucial financing deal for Microbiosensor, and the pivotal role the investment will play in the company bringing its products to market.”
Microbiosensor Secures £1.4m Worth of Equity Finance
By Gordon Barker on 16th November 2017
Microbiosensor is pleased to announce it has secured £1.4m worth of equity finance in the 100th deal completed by the Northern Powerhouse Investment Fund (NPIF), co-investing with the Greater Manchester and Cheshire Life Sciences Fund.
The transaction was made through private equity firms Maven Capital Partners and Catapult Ventures.
The investment from NPIF, supported by the European Regional Development Fund, will give Microbiosensor the capital needed to take its products, namely disposable point-of-care medical devices for the early diagnosis of microbial infections, through critical development and clinical trial phases and bring them to market.
Microbiosensor CEO Dr Gordon Barker said: “We’re delighted to be working with the teams at Maven and Catapult Ventures. This investment will be transformational for the company, funding the pivotal clinical trials we need to take our first medical device product to market.”
Maven investment manager Gavin Bell commented: “Microbiosensor is developing innovative solutions for large global healthcare end-markets with interesting dynamics, including a clear need for technological enhancement and efficiencies. We are delighted to support this highly skilled management team to execute their growth strategy and vision.”
Catapult Ventures life science partner Gareth King commented, “We were attracted to Microbiosensor by the depth of experience of its management team and the simplicity of their technology that is well proven and ideally suited for its target applications for the detection of early stage bacterial infections.”
NPIF is supported financially by the European Union using funding from the European Regional Development Fund (ERDF) as part of the European Structural and Investment Funds Growth Programme 2014-2020 and the European Investment Bank.
Christina Ong, MC2
0161 236 1352
About the Northern Powerhouse Investment Fund
• The Northern Powerhouse Investment Fund will invest in Microfinance, Business Loans and Equity Finance sub-funds which will offer financing ranging from £25,000 to £2m, specifically to help small and medium sized businesses secure the funding they need for growth and development.
• The Northern Powerhouse Investment Fund is operated by British Business Financial Services Limited, wholly owned by British Business Bank, the UK’s national economic development bank. Established in November 2014, its mission is to make finance markets for smaller businesses work more effectively, enabling those businesses to prosper, grow and build UK economic activity,
• The Northern Powerhouse Investment Fund is supported by the European Regional Development Fund, the European Investment Bank, the Department for Business, Energy and Industrial Strategy and British Business Finance Limited, a British Business Bank group company.
• NPIF covers the following LEP areas: Tees Valley Combined Authority, Greater Manchester, Cheshire and Warrington, Cumbria, Liverpool City Region, Lancashire, Humber, Leeds City Region, Sheffield City Region, York, North Yorkshire and East Riding
• The project is receiving up to £140,359,192 of funding from the England European Regional Development Fund as part of the European Structural and Investment Funds Growth Programme 2014-2020. The Department for Communities and Local Government is the Managing Authority for European Regional Development Fund. Established by the European Union, the European Regional Development Fund helps local areas stimulate their economic development by investing in projects which will support innovation, businesses, create jobs and local community regenerations. For more information visit https://www.gov.uk/european-growth-funding.
• The funds in which Northern Powerhouse Investment Fund invests are open to businesses with material operations, or planning to open material operations, in, Yorkshire and the Humber, the North West and Tees Valley.
• The British Business Bank has published the Business Finance Guide (in partnership with the ICAEW, and a further 21 business and finance organisations). The guide, which impartially sets out the range finance options available to businesses and provides links to support available at a regional level, is available at www.thebusinessfinanceguide.co.uk/bbb
Microbiosensor Ltd awarded significant investment in its revolutionary technology aimed at easing A&E pressures
By Gordon Barker on 27th February 2017
Microbiosensor is pleased to announce that it is one of 5 successful companies selected by SBRI Healthcare for a second tranche of investment to continue with product development and testing of new technologies that ease pressure on urgent and emergency care services.
The five companies selected by SBRI Healthcare for the second tranche of investment were drawn from a shortlist of 14 companies that received six months feasibility funding in March 2016. The successful companies demonstrated best value and greatest technical feasibility to a panel of experts looking for game-changing technologies with the highest potential value to patients and the health service. The companies will be supported and fully funded to continue with product development and testing.
Richard Phillips, Chair of SBRI Board and Director of the Association of British Healthcare Industries (ABHI) said: “As demands and pressure on the urgent and emergency care system increase, we need to find new ways to bring high value innovation into the NHS. This announcement will bring new and creative solutions into this space that will improve care for patients and efficiency for the NHS.
About Microbiosensor’s UTI technology:
Urinary tract infections in the elderly are a frequent cause of non-specific confusion and one of the most common, preventable, reasons for emergency admissions to hospital. Microbiosensor is developing a test to show the sensitivity of infecting bacteria to antibiotics. It will be used in primary care, e.g. GP surgeries and elderly residential homes, to aid the rapid, and accurate, prescription of antibiotics to patients with suspected urinary tract infection. During this Phase 2 contract, the device will be developed from a laboratory prototype to a manufacturable product prototype, tested with many patient samples, and ready for final clinical validation.
About SBRI Healthcare: www.sbrihealthcare.co.uk
SBRI Healthcare is an NHS England initiative, led by the country’s 15 Academic Health Science Networks (AHSNs), that co-develops innovative products to address unmet health needs.
Microbiosensor Wins Prestigious UK Innovate award
By Gordon Barker on 9th February 2017
Microbiosensor Limited is pleased to announce that it has been awarded a £983k grant for its proposed project, “Evaluation, prototyping and production pathway of a diagnostic for peritoneal dialysis infection”, as part of Innovate UK’s Biomedical Catalyst 2016 Early Stage Competition.
The grant will be used to develop a simple new test which can help patients with kidney failure, undergoing peritoneal dialysis at home to detect infections at an early stage before they become life threatening. This means that treatment could be started more quickly and the infection controlled more easily. The test also gives additional information to the medical team, allowing them to choose the best treatment. The idea for the new test came from the University of Manchester where researchers have been working on detection of bacteria using a colour change reaction. Microbiosensor are now working to fully develop this test, and a way of manufacturing a reliable, easy to use product.
Gordon Barker, CEO at Microbiosensor, said: “We are pleased to receive this prestigious recognition with a major award from Innovate UK, which will allow us to accelerate the development and clinical evaluation of our disposable point-of-care infection diagnostics for renal dialysis patients and other vulnerable groups.”
About Innovate UK
Innovate UK is the UK’s innovation agency. It works with people, companies and partner organisations to find and drive the science and technology innovations that will grow the UK economy. For further information visit www.innovateuk.gov.uk
Microbiosensor Awarded with Bionow Project of the Year 2016
By Gordon Barker on 6th December 2016
The team at Microbiosensor is pleased to announce that it won the coveted ‘Bionow Healthcare Project of the Year Award’ (sponsored by TRUSTECH), at the 15th Annual Bionow Awards ceremony for its SBRI funded project ‘Reducing admissions through rapid diagnosis of urinary infections in elderly’, The project aimed to develop a prototype simple antimicrobial susceptibility diagnostic to prevent hospital admission due to urinary tract infection.
The Bionow Awards event, held on the evening of Thursday 24th November, celebrated the crème-de-la-crème of life sciences talent in the North of England and sponsored by Manchester Science Partnerships, the awards ceremony recognised the biomedical industry’s highest achievers.
Geoff Davison, chief executive of Bionow, said: “The shortlist for this year’s awards was a who’s who of talent in the northern region and a testament to the strength and depth of the life sciences sector in the North of England.”
Dr Chris Doherty, managing director of Alderley Park, the UK’s largest dedicated life science campus, which is part of Manchester Science Partnerships said: “We are delighted to support these important awards. The biomedical sector is undoubtedly one of the Northern Powerhouse’s key strengths, developing knowledge, creating high-value skilled jobs and attracting investment. The region already has a reputation for world-class science innovations and with businesses like these at the vanguard of the industry, we are confident that the sector will continue to go from strength-to-strength, next year and beyond.”
Microbiosensor wins an award in the first round of GMAHSN’s new Innovation Funds
By Gordon Barker on 9th November 2016
Microbiosensor was recently announced as one of the successful companies to win an award in the first round of GMAHSN’s new Innovation Funds. The Funds: Ignite, Energise and Momentum, were launched earlier this year and focus on different stages of the journey from product development to piloting and roll-out. As one of the winners of the Energise Fund, Microbiosensor has been awarded £50k, which will support a pilot clinical investigation of their PD-Safe device, a monitor designed to identify infection in home dialysis patients.
Gordon Barker, CEO of Microbiosensor said:
“We’re delighted to receive this Energise Fund award and extremely grateful to the GMAHSN team for their support. The award will be transformational for Microbiosensor, allowing us to perform the first clinical trial of our novel infection monitor, “PD Safe”, with patients attending peritoneal dialysis clinics here in Greater Manchester. This will help validate our point-of-care diagnostic technology, pave the way for subsequent (larger) clinical studies and accelerate our progress to market.”
The Best of the UK’s Life Sciences and Healthcare Technology Sector crowned at the 2016 Medilink UK Awards – Microbiosensor wins an award
By Gordon Barker on 10th May 2016
We are pleased to announce that Microbiosensor Limited won runner-up in the “Start-up” category at the Medilink UK 2016 Awards. This award was specifically for newly established companies in the healthcare sector that have been trading up to three years, and show a promising future.
Held at Coventry’s Ricoh Arena as part of the Med-Tech Innovation Expo on 20th April, the Medilink UK Awards celebrate the pinnacle of new technologies, outstanding business achievements and international success across the sector throughout the past year.
The nominees were drawn from winners of regional awards across the UK, selected by panels from Medilink UK member organisations.
Microbiosensor wins £100k in a competitive tender organised by SBRI Healthcare
By Gordon Barker on 19th April 2016
Microbiosensor has successfully applied for and won a £100,000 development contract in a competitive tender organised by The Small Business Research Initiative for Healthcare (SBRI Healthcare).
SBRI Healthcare, an NHS England funded initiative to develop innovative products that address unmet health needs, recently announced Microbiosensor as being one of the 14 companies that will share £1.4 million to develop products that can significantly impact the increasing pressures being put on urgent and emergency care services.
The number of attendances at A&E has risen significantly over the last decade putting pressure on urgent and emergency care services and increasing waiting times. According to the Kings Fund, 21.7 million visited A&E in 2013/14, a greater than 30% rise in the last decade. More than 70% of hospital bed days are occupied by A&E admissions and 80% of A&E admissions who stay for more than two weeks are patients aged over 65. SBRI Healthcare invited companies to specifically turn their minds to developing products that will help patients, clinicians and managers deliver high-quality and efficient urgent and emergency care.
Microbiosensor’s response was an exciting feasibility study aimed to reduce A&E admissions through rapid diagnosis of urinary tract infections, which are the 3rd most common reason for emergency admissions to hospital from A&E departments. The company will use its innovative platform technology to develop a low-cost diagnostic device, designed for use with existing urinary catheter systems. This device will assess bioburden and antimicrobial sensitivity at the point of care and give a more rapid read-out than conventional microbiology testing. The funding will be used to develop working prototypes, ready for early stage clinical testing.
SBRI Healthcare is an NHS England initiative, championed by the Academic Health Science Networks (AHSNs), who aim to promote UK economic growth whilst addressing unmet health needs and enhancing the take up of known best practice.
Part of Innovation Health and Wealth the SBRI Healthcare programme sets industry the challenge in a series of health related competitions which result in fully funded development contracts between the awarded company and the NHS. Unlike many R&D projects which offer grant or match funding, SBRI contracts are 100 per cent funded and the company retains the IP.
The views expressed in this article are those of Microbiosensor Limited and not necessarily those of the SBRI Healthcare programme or its stakeholders.
Microbiosensor Wins ‘The Start-Up Award’ at the Medilink Northwest Healthcare Business Awards 2016
By Gordon Barker on 16th February 2016
Microbiosensor is pleased to announce that it won a coveted award at the Medilink Northwest Healthcare Business Awards, held at the Victoria Warehouse in Manchester on Friday 12th February. This annual award ceremony, attended by the sector’s leading business people, clinicians, academics and key opinion leaders, is recognised as a premier event in the region’s Healthcare Technology calendar and the company was delighted to receive the winning prize for the category ‘Start Up Company’ of the Year.
Dr Curtis Dobson, co-founder, comments: “We are absolutely delighted to receive this award. This success reflects the dramatic progress Microbiosensor Limited has made over last 2 to 3 years in translating University research into a tangible product, with the potential to deliver substantial economic and healthcare impacts across Europe. The Award will give the team a further boost as we move forward with our ambitious plans to gain a CE mark for our first product this year.”