Digital Transformation & AI Manager (Regulatory & Quality)

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 RAQA Automation Delivery 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 #LI-PG2 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 Biocare Envista 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. Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care. Envista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com.