Regulatory Affairs Manager, MedTech & AI Compliance

Nobel Biocare; Kloten; On-site; CHF 130,000 - 170,000; Full time

Job summary

Nobel Biocare is seeking a Regulatory Affairs Manager to lead regulatory deliverables for EU, US, and Canada across prosthetic and digital devices. The role emphasizes strategy, submissions, and lifecycle management, with a focus on responsible AI and automation to enhance regulatory processes.

The ideal candidate brings 5+ years in regulatory affairs for medical devices, with direct experience with authorities and strong knowledge of EU/US/CA regulations. Fluent English required.

Qualifications

• 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 Canada medical device regulations.
• Knowledge of ISO 13485 quality management system requirements.
• Experience devising regulatory strategies and conducting impact assessments.
• Experience interpreting changed legislation and implementing it in processes.
• Foundational knowledge of AI and automation with responsible use considerations.
• Fluency in English; additional languages are an advantage.

Responsibilities

• Develop regulatory strategies for CE/UKCA, 510(k) and Health Canada submissions.
• Manage regulatory compliance across product lifecycle and PMS activities.
• Support audits, technical file reviews, and regulatory documentation updates.
• Execute product registrations and ensure compliant UDI submissions.
• Provide regulatory guidance for labeling, IFU/eIFU, and lifecycle changes.
• Identify AI/automation opportunities to improve regulatory processes while ensuring governance.

Skills

Regulatory affairs knowledge

EU/US/CA regulatory knowledge

Quality management ISO 13485

Design control process

Post-market surveillance

AI & automation awareness

English fluency

Education

Bachelor's degree in technology or science

Master's degree (advantage)

PhD (advantage)

Job description

Nobel Biocare is seeking a Regulatory Affairs Manager to lead regulatory deliverables for EU, US, and Canada across prosthetic and digital devices. The role emphasizes strategy, submissions, and lifecycle management, with a focus on responsible AI and automation to enhance regulatory processes.

The ideal candidate brings 5+ years in regulatory affairs for medical devices, with direct experience with authorities and strong knowledge of EU/US/CA regulations. Fluent English required.