Quality and Regulatory Manager

Health Innovation Research Alliance Northern Ireland; Belfast; Hybrid; GBP 45,000 - 65,000; Full time

Job summary

A leading health innovation organization is searching for a Quality and Regulatory Manager to ensure compliance with industry standards. This role involves leading quality projects, managing GDPR processes, and maintaining ISO certifications while empowering the team's expertise. The position offers a flexible work schedule and significant benefits aimed at professional development.

Benefits

Employer pension contribution

Flexible working including Flexi Fridays

Enhanced Maternity/Paternity Leave

Training budget

Home office furniture budget

Qualifications

• Experience in software development quality within regulated environments.
• Working knowledge of ISO 27001 and data protection legislation.
• Strong communication and teamwork skills.

Responsibilities

• Lead projects for implementing ISO 27001, EU Cyber Resilience Act.
• Manage GDPR processes and data protection compliance.
• Oversee internal audits of the Quality Management System.

Skills

Quality Management

Data Protection

Regulatory Compliance

Education

Lead Auditor certification

Job description

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)

Manage Consent

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