We are currently looking for an experienced QA & Compliance Manager to join a long-term international project in the fields of digital health, biomedical research, and regulated IT systems.
Be one of the first applicants, read the complete overview of the role below, then send your application for consideration.
This is an excellent opportunity for a senior professional with a strong background in quality assurance, regulatory compliance, data protection, and software quality management within highly regulated environments.
Key Responsibilities
* Organize activities to support project delivery.
* Lead software testing activities.
* Lead software quality activities.
* Validate software testing and software quality outputs.
* Work closely with other members of the project team.
* Work within an Agile project environment
Required Qualifications & Experience
At least 5 years of experience with EU data protection law and GDPR compliance, including:
* Software and systems compliance
* Data Protection by Design and by Default
* Data Protection Impact Assessments (DPIAs)
* Controller-Processor Agreements
Experience with Intellectual Property Rights (IPR) compliance and approaches to managing IP as part of science and/or technology-based collaborations and partnerships.
Quality assurance and compliance experience in computational biomedicine or biomedical research.
Experience with regulatory frameworks relevant to IT solutions developed for use in:
* Clinical decision support
* Clinical trials
Examples include:
* Medical Devices Regulation (EU) 2017/745
* Clinical Trials Regulation (EU) 536/2014
* Health Technology Assessment Regulation (EU) 2021/2282
* Ethical approvals
Experience in monitoring and improving compliance, including internal and statutory audits as part of software development and regulated systems' IT operations.
Experience working in Agile project environments. xphnsxz
Language Requirement
English proficiency equivalent to:
* C1 level in reading and understanding
* B2 level in spoken communication
Additional Information
* Location: Remote within the European Union
Candidates must be comfortable working in structured, security-focused environments.
If you are interested, please read carefully the privacy policy available here and submit your application by attaching your CV. We remind you that, pursuant to Article 111-bis of the Privacy Code, it is not necessary to obtain authorization for the processing of personal data contained in your CV.