Seargin is a dynamic multinational tech company operating in 50 countries. At Seargin, we drive innovation and create projects that shape the future and greatly enhance the quality of life. You will find our solutions in the space industry, supporting scientists in the development of cancer drugs, and implementing innovative technological solutions for industrial clients worldwide. These are just some of the areas in which we operate.
IT Security Expert
Remote
EU
B2B
Senior
Perform qualification activities for service provider's digital compliance partners, including Contracted Research Organizations (CROs), Central Laboratories, and providers of digital healthcare solutions, digital biomarkers, medical devices, and software as medical devices (SaMD)
Provide computerized system expertise to support business partners in the selection and management of service providers
Offer support to clinical study teams with digital compliance-related issues for service providers to ensure smooth project execution
Oversee service provider's digital risks, including reviewing mitigation plans and delivered evidence to ensure high risks are properly mitigated
Conduct vendor risk assessments to evaluate whether third parties have appropriate compliance controls and business disciplines to minimize risks
Leverage the technical expertise of internal teams and external technology providers and vendors to deeply understand and manage risks
Maintain expert-level knowledge of the dynamic health authority governance to ensure compliance and inform risk management strategies
Act as a trusted partner for business and procurement teams and stakeholders throughout the organization, including Business Quality
Employment based on a B2B contract
Opportunity to work in a stable, dynamically developing international company
Chance to participate in interesting projects and work with the latest information technologies
Attractive remuneration rates offered
Involvement in the most prestigious international projects
Access to Multisport benefits and private healthcare services
Have 5+ years of experience in a large global enterprise IT environment within quality assurance for software development, preferably in the medical device industry
Hold a BA or BS in informatics, life science, business, or equivalent; MA or MS and post-graduate coursework are desirable
Possess practical knowledge of FDA 21 CFR Part 11, FDA 21 CFR Part 820, EMA Annex 11, EMA MDR, IVDR regulations, and ISO 13485 standard
Have experience in quality assurance for software development as a medical device to ensure compliance and quality standards are met
Demonstrate a strong understanding of risk management principles and methodologies to effectively mitigate and manage risks
Understand Software Development Life Cycle methodologies, including Agile, to support and improve development processes
Have an understanding of the drug development process to integrate quality assurance practices within this context
Understand Privacy Regulations (e.g., GDPR, HIPAA) and their application to service providers to ensure data protection and compliance
Possess professional experience in audits, risk management, IT security, or IT privacy to enhance quality assurance practices (desirable)
Experience leading cross-functional collaborative team environments, providing innovative solutions to complex business problems, and making decisions with cross-functional impact
Exhibit strong communication skills to convey complex information, issues, and potential solutions at an executive level
Demonstrate proven skills in relationship building, customer focus, decision-making, and problem solving
Show the ability to quickly learn business priorities in unfamiliar or ambiguous areas to effectively adapt and contribute
