Regulatory Affairs Lead – Medical Devices & AI-Driven Compliance

Envista Holdings Corporation; Kloten; On-site; CHF 140,000 - 190,000; Full time

Job summary

Nobel Biocare Envista is seeking a Regulatory Affairs Manager responsible for EU, US and Canada regulatory deliverables for prosthetic and digital devices, spanning development, compliance projects, and lifecycle management.

You will develop regulatory strategies, lead CE/UKCA, 510(k) and Health Canada submissions, maintain technical files, support PMS, audits and post-market activities, and explore AI-enabled improvements while preserving human oversight.

Qualifications

• Bachelor’s degree from accredited college or university.
• Master’s degree or PhD is advantageous.
• A tech or science-focused degree is preferred.
• Minimum 5 years’ experience in regulatory affairs within medical device industry.
• Minimum 3 years' experience working directly with authorities.
• In-depth knowledge of EU, US and CA medical device regulations.
• Knowledge of ISO 13485 quality management system requirements.
• Knowledge of design control and technical documentation for medical devices.
• Experience devising regulatory strategies and impact assessments.
• Experience interpreting changed legislation and implementing it in processes.
• Software, cybersecurity risk management and PMS experience is an advantage.
• Foundational knowledge of AI and automation with governance considerations.
• Fluency in English is a must.
• Additional languages are an advantage.

Responsibilities

• Manage regulatory aspects of developing new prosthetic and digital devices.
• Develop regulatory strategies and assemble CE/UKCA marking, 510(k) and Health Canada submissions.
• Manage regulatory compliance throughout lifecycle, including change requests, PMS and technical files.
• Support audits and front/back-office audit activities.
• Ensure accurate, timely and compliant UDI submissions and data integrity.
• Provide regulatory guidance on labeling, IFU and software/digital solutions.

Skills

Regulatory strategy

Regulatory submissions

Quality management systems

AI in regulatory

English fluency

Education

Bachelor’s degree

Master’s degree

PhD

Job description

Nobel Biocare Envista is seeking a Regulatory Affairs Manager responsible for EU, US and Canada regulatory deliverables for prosthetic and digital devices, spanning development, compliance projects, and lifecycle management.

You will develop regulatory strategies, lead CE/UKCA, 510(k) and Health Canada submissions, maintain technical files, support PMS, audits and post-market activities, and explore AI-enabled improvements while preserving human oversight.