Business Systems Analyst - Digital Solutions (Regulatory & Quality)
Job Description:
Business Systems Analyst - Digital Solutions (Regulatory & Quality)
PURPOSE
The Business Systems Analyst - Digital Solutions partners with Regulatory Affairs and Quality Assurance (RAQA) subject matter experts and leadership to identify opportunities, develop prototypes, and support implementation of digital solutions that contribute to the RAQA digital roadmap.
The role helps reduce manual workload, improve data quality and consistency, strengthen compliance robustness, and enable practical adoption of automation and AI-enabled solutions within a regulated medical device environment.
The role collaborates with IT on digital initiatives related to IT-managed systems and on architecture and scalability when broader deployment or enterprise support is required.
ACCOUNTABILITIES
Prototyping and Digital Solutions
Partner with RAQA SMEs to understand pain points, data flows and user needs.
Develop prototypes, proof-of-concepts and selected departmental automation and AI-enabled solutions to help RAQA teams evaluate opportunities, refine requirements and improve efficiency.
Apply automation and AI tools to support document compilation and reuse, data validation, consistency checks, structured content reuse and automation of repetitive RAQA tasks.
Collaborate with IT and SAP teams on architecture decisions, system integrations, deployment, data privacy, security and industrialisation when broader scalability is required
Enterprise Systems & IT Solutions
Act as the primary RAQA contact for selected IT-managed systems and digital initiatives with the goal of improving efficiency, data consistency and automation of RAQA processes.
Gather, document and maintain business requirements for enterprise solutions, e.g. SAP-based solutions and related integrations.
Collaborate with IT and external vendors during solution design, implementation and life-cycle management activities.
Support testing, validation, user acceptance activities and documentation for new implementations and system changes.
Digital & AI‑Enabled Solutions
Apply automation and AI tools to support document compilation and reuse, data validation and consistency checks, automation of repetitive quality and regulatory tasks
Build automation workflows using approved tools (e.g. Python, UIPath, Power Apps)
Collaborate with IT and SAP teams on architecture decisions, system integrations, security and access design
Support selection and effective use of preferred tools, vendors, and development approaches within RAQA
Validation, Compliance & Documentation
Ensure digital solutions are appropriately tested, validated and documented, and compliant with applicable quality and regulatory requirements
Produce and maintain requirements, design documentation, test evidence, validation records, release notes, user guidance and traceability artifacts.
Support audit readiness and ensure that changes to digital solutions are managed in a controlled and maintainable way.
Enablement & Continuous Improvement
Promote automation and digital mindset within RAQA
Support the development of a structured framework for automation and AI responsible use
Continuously assess opportunities for scalability, maintainability, compliance robustness and user adoption
Job Requirements:
Education
- Bachelor’s or Master’s degree in Regulatory Affairs, Quality, Life Sciences, or Engineering, Computer Science, or equivalent
Experience & knowledge
Experience with process improvement, automation, or digitalizatio
Experience in medical devices or regulated industries is advantageous
Working knowledge of ISO 13485, GxP validation principles or controlled documentation processes is advantageous
Fluency in English is a must
Technical Skills
Practical ability to create prototypes, scripts or small digital solutions using scripting/coding (e.g. Python), AI-assisted development and/or automation tools.
Experience with Word/Excel automation, structured data handling, APIs, data validation and application logic is strongly preferred.
Exposure to AI-enabled tools, agents, RAG concepts, or similar digital technologies is advantageous.
Practical experience with version control tools (e.g., GitHub) and exposure to AI-assisted development environments.
Familiarity with SAP, SharePoint, Microsoft 365, cloud concepts, information security and GDPR/data privacy is an advantage.
Operating Company:
Nobel BiocareEnvista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.
