Digital Transformation & AI Manager (Regulatory & Quality)
Job Description
Job Description:
PURPOSE
The Digital Transformation & AI Manager (Regulatory & Quality) is a hands‑on Regulatory Affairs and Quality Assurance (RAQA) professional who drives the practical adoption of automation and digital solutions across Regulatory and Quality processes.
The role is designed to reduce manual workload, improve data quality and consistency, and enable compliant, scalable automation within a regulated medical device environment.
The role combines RAQA domain expertise with applied automation and AI capabilities, acting as a bridge between business needs, digital tools, and compliant implementation approaches.
ACCOUNTABILITIES
RAQA Process Execution & Optimization- Analyze RAQA processes and leverage hands-on process experience to identify automation opportunities
- Support process owners in improving workflows toward standardization, automation, and data reuse, ensuring solutions are practical and adoptable
- Design and implement end-to-end automation solutions to streamline and optimize key RAQA processes
- Collaborate with RAQA leadership to support more complex automation initiatives, including cross-system, high-risk, or enterprise-wide processes
- Own automation solutions through their full lifecycle: design, build, validation, deployment, and maintenance
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. Power Automate, Power Apps, UiPath, Python, low‑code solutions)
- 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 all automation solutions are validated, documented, and compliant with applicable regulatory and quality system requirements
- Produce and maintain documentation suitable for regulated environments: requirements and design documentation, validation and test evidence, release notes and traceability artifacts
Enablement & Continuous Improvement
- Promote automation and digital mindset within RAQA
- Support the development of a structured automation framework
- Continuously assess opportunities for improvement and scalability
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 digitalization
- Experience in medical devices or regulated industries
- Hands-on experience or strong exposure to Regulatory Affairs or Quality Assurance processes is preferred
- Solid working knowledge of ISO 13485 and GxP validation principles
- Familiarity with MDR / IVDR and FDA is an advantage
- Fluency in English is a must
Technical Skills
- Experience with automation tools (e.g., Power Automate, UiPath, or similar)
- Experience with data handling or scripting (e.g., Python, Visual Basic, advanced Excel)
- Exposure to AI, data, or digital technologies
- Practical experience with version control tools (e.g., GitHub) and exposure to AI-assisted development environments (e.g., GitHub Copilot)
- Familiarity with SAP, SharePoint, or similar enterprise systems 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.