Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead quality projects and manage compliance with data protection regulations.
- Company: Join Sonrai, a Belfast-based AI company transforming healthcare through data insights.
- Benefits: Enjoy flexible working, enhanced maternity/paternity leave, and a strong focus on staff development.
- Why this job: Make a real impact in precision medicine while working in a dynamic, collaborative environment.
- Qualifications: Experience in software development quality and knowledge of ISO standards required.
- Other info: This is a 12-month maternity cover contract with a mix of onsite and remote work.
The predicted salary is between 36000 - 60000 £ per year.
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.
Our Mission is to Empower Precision Medicine Through AI Innovation, 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 to identify 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.
The person:
A detail-orientated, proven multi-tasker 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
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
Employer pension contribution
Flexible working available including Flexi Fridays and No Meeting Fridays
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)
#J-18808-Ljbffr
Quality and Regulatory Manager employer: HIRANI
Contact Detail:
HIRANI Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality and Regulatory Manager
✨Tip Number 1
Familiarise yourself with ISO 27001 and the EU AI Act, as these are key components of the role. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to the position.
✨Tip Number 2
Network with professionals in the biotech and pharma sectors, especially those who have experience with quality management systems. Engaging with industry experts can provide insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss your experience with data protection legislation, particularly GDPR. Be ready to share specific examples of how you've implemented compliance measures in previous roles.
✨Tip Number 4
Showcase your collaborative skills by highlighting past experiences where you've worked with cross-functional teams. This is crucial for the Quality and Regulatory Manager role, as you'll be leading projects with various subject matter experts.
We think you need these skills to ace Quality and Regulatory Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality management and regulatory compliance, particularly in relation to ISO 27001 and GDPR. Use specific examples that demonstrate your ability to manage quality projects and compliance processes.
Craft a Compelling Cover Letter: In your cover letter, express your passion for precision medicine and AI innovation. Mention how your skills align with Sonrai's mission and the specific responsibilities of the Quality and Regulatory Manager role. Be sure to include any relevant certifications, such as Lead Auditor certification.
Showcase Your Soft Skills: Highlight your detail-oriented nature, collaborative abilities, and self-motivation in both your CV and cover letter. Provide examples of how you've successfully worked in dynamic environments and adapted to changing needs.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for the Quality and Regulatory Manager position.
How to prepare for a job interview at HIRANI
✨Understand the Regulatory Landscape
Familiarise yourself with ISO 27001, EU Cyber Resilience Act, and EU AI Act. Be prepared to discuss how your experience aligns with these regulations and how you can contribute to maintaining compliance at Sonrai.
✨Showcase Your Quality Management Experience
Highlight your previous roles in managing quality systems, especially in regulated environments. Discuss specific projects where you implemented or improved quality management processes, particularly in relation to ISO 13485.
✨Demonstrate Your Team Collaboration Skills
As a Quality and Regulatory Manager, you'll need to work closely with various teams. Prepare examples of how you've successfully collaborated with cross-functional teams in the past to achieve common goals.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities in real-world situations. Think of scenarios where you had to identify regulatory gaps or manage compliance issues, and be ready to explain your approach and outcomes.
