Quality and Regulatory Manager
Job Type: Non-permanent - Maternity Leave Cover
Reports to: Head of Operations
Salary: Information available on application
Location: Hybrid - Belfast (2 days) and home working (3 days)
About Us
Sonrai is a Belfast-based AI data discovery company that helps Biotech and Pharma companies get maximum value from their data.
Sonrai started in response to a growing need within precision medicine for a platform that could integrate large-scale multi-omic data types and generate significant insights and hypotheses, leading to the discovery of novel therapies and biomarkers. Our guiding light is to improve diagnosis and treatment for patients worldwide.
OurMissionistoEmpowerPrecisionMedicineThroughAIInnovation, to elevate Healthcare analytics, and to support new and better solutions to fight disease, develop treatments faster, and improve patient outcomes.
We simplify complicated, difficult, or expensive engineering, data science, and bioinformatics tasks to empower healthcare organisations to make the most of their data with minimal required effort or expertise. We do this via our Discovery Platform, coupled with our team’s experience and expert knowledge, who work hand-in-hand with our clients to help them achieve their vision.
Today, Sonrai is empowering data scientists, biologists, translational researchers and business leaders around the world toidentify high-value biomarkers, validate state-of-the-art algorithms and bring new drugs to market much faster.
Sonrai is currently partnering with several key biotechnology and pharma companies to facilitate the discovery, development and delivery of biomarkers that will enable the early detection and diagnosis of a range of different diseases and indications.
Opportunity & Responsibilities
The Quality and Regulatory Manager role is an anticipated 12 month contract for maternity cover, with onsite office work in Belfast 2 days a week and home-working 3 days a week. Preferably the contract will start as soon as possible to ensure adequate handover.
The main tasks the Quality and Regulatory Manager will be responsible for include:
●leading on Quality projects to implement applicable requirements of ISO 27001, the EU Cyber Resilience Act and the EU AI Act, with a nominated set of subject matter experts across the business,
●managing and maintaining processes for EU and UK GDPR, and UK Data Protection Act, identifying and implementing new data protection requirements for new markets Sonrai, and supporting the Data Protection Officer in customer requests,
●managing and maintaining the certified ISO 13485 Quality Management System, including performing internal audits,
●maintaining quality system and product compliance by identifying new and changes regulatory obligations that affect Sonrai’s business and customers, this includes performing gap assessments and building compliance and implementation plans with the support of subject matter experts across the business,
●acting as Management Representative, and
●depending on the experience of the selected candidate, there may be line management of 1 Officer level staff member.
Essential Criteria
The person:
●A detail-orientated, proven multitasker who can adapt to the needs of a small dynamic business
●Team player with strong collaborative abilities and communication skills
●Self-motivated with a growth mindset
● Right to work in the UK
●Proficient to a relevant level of Business English
The experience:
●Software development quality experience, can be with medical devices, drug development or another regulated environment
●ISO 27001 working experience and knowledge
●Data Protection legislation experience, minimum EU and UK GDPR
●Lead Auditor certification
Desirable Criteria (what you will learn at Sonrai!)
●Experience working in an ISO 13485 certified QMS with EN 62304, ISO 14971 product development standards
●US data protection legislation experience
●Knowledge/awareness of the AI Act and Cyber Resilience Act
●Awareness of AWS as cloud infrastructure
●EU IVDR 2017/746 or EU MDR 2017/745 and UK Medical Device Regulation experience
Sonrai Employee Benefits
●Competitive salary
●Employer pension contribution
●Hybrid working
●Flexible working available including Flexi Fridays and No Meeting Fridays
●25 days leave plus 10 public/bank holidays (pro rata)
●Membership of Westfield Health Plan
●Enhanced Maternity Leave (including 16 weeks at full pay) and Paternity Leave (2 weeks at full pay), once probationary period is successful
●Training budget / strong focus on staff development
●Equipment / working from home budget (up to £300 for home office furniture)
More than a Job
We’re working with global research leaders and industry powerhouses to enable and support truly life-changing advancements within healthcare analytics, bioinformatics, and precision medicine. We’re driven by the potential impact our products might have on supporting ground-breaking predictions and we’re seeking passionate individuals to help us accelerate those plans.
To apply, please send a CV and covering letter outlining how you meet the above criteria, together with a completed Equal Opportunities Monitoring Form, to Alice Geaney at a.geaney@sonraianalytics.com
For data protection reasons Sonrai retains CVs and other pertinent information of applicants for 6 months after application, following this, records are deleted. Sonrai does not retain CVs on file for future roles. Please refer to our Privacy Policy on our website for further details.
Don’t meet every single requirement? At Sonrai, we're committed to fostering a diverse, inclusive, and authentic work environment where employees know they are valued, respected and heard. If you're enthusiastic about the position but don't match every qualification, we urge you to apply. You could be an ideal fit for this or other roles.
If you have a disability and require adjustments through the recruitment process, please email a.geaney@sonraianalytics.com to let us know and Sonrai will endeavour to make reasonable adjustments.
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