Risk Specialist
Would you like to be part of an organisation which is committed to improving patient lives worldwide through education, collaboration and innovation?
Do you want to make a difference?
If the answer is ‘yes’ then you’re just the kind of person we’re looking for!
Working as a Risk Specialist reporting to our Risk Manager. The post holder will be responsible for reviewing all Risk Management files and supporting the wider QA team to ensure that the quality management system meets all required standards.
Main duties will include:
- Facilitate the completion of Risk Assessments.
- Facilitate the completion of Failure, Mode and Effects Analysis.
- Regularly review Risk Management Files for all our products according to the schedule.
- Communicating with all areas of our business to ensure review/completion of Risk documentation as required.
- Be able to gather information from the Post Market Surveillance Process, Customer Case Process, Change Control, CAPA, Adverse Events and other sources as required.
- Update Risk Management Files via Document Control process on our ERP system.
- Awareness of the requirements of the Risk Management System, able to advise where enquiries arise and ensure the system is fully followed at all times.
- Attend design and development meetings as required and advise where Risk enquiries arise.
- Approve Product Risk Landscapes.
- Maintenance and revision of Risk documents and SOPS, detect and correct inaccuracies, suggest improvements.
- General administration duties.
- To obtain a broad overview companywide and within our Quality System Requirements to be able to support the QA Specialists and QA department in terms of advising all with general quality system enquiries.
Knowledge and Skills
Essential Skills:
- A good relevant Scientific degree in Biological Sciences
- Comprehensive knowledge of Quality Systems within a science industry background
- Good Knowledge of standards ISO14971, ISO13485 and regulations IVDR and FDA Part 820
- Experience of working within a QA or RA environment within an IVD or medical device company
- Great attention to detail & written skills.
Working for us:
Founded in 1986 by a group of former researchers based at the University of Birmingham, Binding Site is today recognised as a market leader in the development of products for the investigation of a range of disorders involving immunodeficiency.
The Company is built on the success of its people and values them as its key asset. Integral to Binding Site is creating a diverse and inclusive culture which welcomes and creates diversity of thought, action, and innovation where all 1,200 colleagues can truly thrive. Support and continuous education is reinforced through partnerships with organisations such as Stonewall.
With a strong focus on building a sustainable future for its workforce and local communities, Binding Site has high aspirations for continuous improvement and ensuring their people contribute to their future vision. In addition, Binding Site has recently been recognised at the 2021 Birmingham Post Business Awards, winning both “Company of the Year” and “International Trade and Export” Awards.
Working at Binding Site means being part of a global, award-winning community that delivers innovative solutions with shared ideas and a collective dedication to improving patient lives, worldwide.
Location: Birmingham- Calthorpe Road Edgbaston
Hours: 40 hrs - (Hybrid 3days Birmingham office base 2 days WFH)
Benefits:
Competitive Salary
Contributory Pension
25 days paid holiday plus bank holidays.
Life assurance
Medicash- Health Benefit