Vacancy: Quality & Regulatory Affairs Specialist
Genedrive®, is an affordable, real-time PCR system that can serve as the basis for rapid detection, quantification, or drug resistance testing of infectious diseases and pathogens, such as TB or Hepatitis. As we further develop our Point of Care solutions through assay development and product refinement, we have an opportunity to reach millions of people who currently have limited access to existing diagnostic technology. Ultimately, Genedrive has the ability to change lives through rapid access to the benefits of molecular diagnostics. As we ramp up our focus on delivering affordable point of care in vitro molecular diagnostics for addressing global infectious disease challenges, we are looking to strengthen our Quality Team with the addition of another Quality & Regulatory Affairs Specialist.You can find out more about us by looking at our Company pages at: http://www.genedriveplc.com/
As one of our Quality & Regulatory Affairs Specialists you will report to our Director of Quality & Regulatory Affairs you will have the following key responsibilities:
Participate fully as a member of the Quality Team within and across the business.
Direct Quality and Regulatory support to all departments within the business.
Collaborate with internal and external stakeholders to ensure all our processes comply with the relevant standards and regulations.
Collate and provide KPI’s, trend data and statistical analysis for Management Review and any other review boards where requested.
Provide guidance on Risk Management activities.
Provide guidance, support and maintain the Non-Conformance/Deviation system.
Provide guidance and perform Root Cause Analysis into CAPA investigations.
Assist in the review of Technical, Medical Device and Design History Files.
Create, review, advise and provide guidance on interpretation of SOP’s.
Review, advise and provide guidance on interpretation of Regulatory requirements.
Review Verification and Validation Data Reports and SOP’s and provide support during the Validation activities.
Provide assistance with the maintenance of the electronic and hardcopy record archives.
Perform Audits to a predefined schedule
Participate and support in external Inspections and Audits with clients, distributors and Notified Bodies.
Perform other appropriate duties as assigned.
Provide support and guidance for new product development projects.
What sort of person are we are looking for?
To perform the job successfully, we are looking for an individual who can demonstrate the following competencies:
Attention to detail.
Organisational and prioritisation skills.
Strong written and verbal communication skills.
Ability to work alone
Ability to work part of a team.
Working knowledge of ISO 13485
Ideal / Desired Experience & Qualifications:
Where will I be working?
You will be based at our offices at the Incubator Building within the University of Manchester Innovation Centre, on Grafton Street, off Oxford Road in central Manchester.
Hours of Work
You will be required to work 37.5 hours per week between the hours of 8.00am and 6.00pm. You can discuss your ideal start and finish times with us.
We provide Private Healthcare, Death in Service Benefit, Group Income Protection, Share -Option Scheme, 25 days holiday plus 8 statutory bank holidays) per year, discretionary bonus and a Group Personal Pension scheme.
How to apply
If you would like to apply for the role of Quality & Regulatory Affairs Specialist, please send in your CV with a covering letter to us via our email at: Careers@genedrive.com
Please focus on telling us how your skills and experience match the type of person we are looking for and why you believe you would be an ideal candidate for the role of Quality & Regulatory Affairs Specialist.
Closing Date: Monday 1st April 2019
Business Development Manager
LifeArc is the new name for MRC Technology, a medical research charity with a 25 year legacy of helping scientists and organisations turn their research into treatments and diagnostics for patients.
LifeArc is pioneering new ways to turn great science into greater patient impact. It brings together a network of partners to tackle specific diseases and directly funds academic and early stage research. We want to help deliver cutting edge science to benefit as many patients as possible.
Our track record of success has given us the financial power to think differently and invest in the health changes we really believe in.
The role will have three main purposes, firstly to source new and early stage projects from the academic sector; secondly to identify strong commercial partners and establish productive collaborations; thirdly to out-license or partner assets generated from the activities of the Centre for Diagnostics Development.
The ideal candidate will be a ‘self-starter’ able to take initiative and work with minimal supervision. You will have good interpersonal skills, be extremely well organised with experience of using CRMs and other business software tools. You will have excellent understanding of the Dx sector, the technologies and the science behind Molecular Dx tests.
You will have significant diagnostics industry experience in a product development, marketing or sales role. Experience of selling into or working with the NHS. Experience of identifying market needs and working with KOLs to understand the needs of the medical community and patients.
You will preferably have a PhD in life sciences or a masters with significant experience (at least 5 years) in the diagnostics industry.
Your salary will be determined by qualifications and experience. In addition, LifeArc offers a defined contribution pension scheme, private health insurance, a flexible benefits scheme and 31 days paid holiday per year.
LifeArc is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all.
To apply please email your CV and covering letter explaining why you want to work for LifeArc to: firstname.lastname@example.org
Closing Date: 22nd March 2019