Overview
Sonrai is a Belfast-based AI precision medicine company that helps Biotech and Pharma companies get maximum value from their data, with a mission to power the most important precision medicine breakthroughs through connected data and collaborative science. We enable our customers to reduce the cost, time, and risk from early discovery to clinical trials, accelerate drug, biomarker, and diagnostics development, maintain a secure and compliant Trusted Research Environment, and effectively and safely manage data. Our bioinformatic cloud product, Sonrai Discovery, is sold on a license fee basis, along with accompanying data science and software engineering professional services. Our clients and partners already include some of the biggest names around, and we’re now looking to appoint a Senior Quality and Regulatory Engineer to help deliver our strategy.
It’s a great time to be joining Sonrai; over the past two years, we have grown our customer base across a range of biotech and pharma organizations globally, expanded our team to 35+, and won multiple awards.
Opportunity & Responsibilities
The Senior Quality and Regulatory Engineer role is a permanent position, with onsite office work in Belfast at least 2 days a week and home-working. The role reports into the Quality and Regulatory Manager (and Head of Operations during maternity leave period, with ongoing direction from an external Quality and Regulatory consultant). Sonrai is looking to fill this role as soon as possible.
The Senior Quality and Regulatory Engineer will be responsible for:
* leading on quality projects to implement applicable requirements of ISO 27001, 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, and supporting the Data Protection Officer in customer requests
* managing and maintaining Sonrai’s Quality Management System and certification, with support from the consultant, including performing internal audits
* maintaining quality system and product compliance by identifying new and changing regulatory obligations that affect Sonrai’s business and customers, including gap assessments and building compliance and implementation plans with support from subject matter experts across the business
* supervision of 1 officer-level staff member
The person:
* A detail-oriented, 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 or Ireland for a minimum of 2 years from the date of any job offer from Sonrai
* 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
* Proven, direct ISO 27001 working experience and knowledge
* Data Protection legislation experience, minimum EU and UK GDPR
* Proven internal auditing experience
Desirable Criteria (what you will learn at Sonrai!)
* Experience working in a certified ISO Quality Management System, such as ISO 9001, ISO 13485 with EN 62304, ISO 14971 product development standards
* Knowledge/awareness of the AI Act and vulnerability management processes
* Awareness of AWS as cloud infrastructure
* EU IVDR 2017/746 or EU MDR 2017/745 and UK Medical Device Regulation experience
Sonrai Employee Benefits
* 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)
* Membership of Women in Business Northern Ireland
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 12 months after application, following this, records are deleted. Sonrai does not retain CVs on file for future roles. By submitting your application, you consent to the processing of your personal data for the purposes of recruitment and in accordance with applicable data protection laws and regulations. Please refer to our Privacy Policy on our website for further details.
If you have a disability and require adjustments through the recruitment process, please let the contact on the Job Description know; Sonrai will endeavour to make reasonable adjustments.
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