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.

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Job details

Operating Company:

Nobel Biocare

Location:

CZE - Praha - Multiple Opcos

Date Posted:

2026-06-16

Req Number:

R5026514

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Digital Transformation & AI Manager (Regulatory & Quality)

Digital & AI‑Enabled Solutions

Validation, Compliance & Documentation

Enablement & Continuous Improvement

Caring for our employees and their families

Our hiring process

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