Global Regulatory Affairs Manager – Electrical Devices

Ivoclar EMEA; Naturno; Sur place; EUR 40 000 - 48 000; Plein temps

Résumé du poste

Ivoclar EMEA in Naturno, Italy seeks a regulatory affairs specialist for electrical devices and medical devices to develop regulatory strategies, coordinate international registrations, and manage documentation across the product lifecycle.

You will collaborate with Development, Sales, and Marketing, monitor regulatory changes, support CAPA and NC handling, and ensure timely approvals with a focus on cross-functional teamwork and pragmatic problem solving.

Qualifications

• Bachelor’s degree in medical technology, electrical engineering, electronics, mechanical engineering, or a comparable qualification.
• Several years of experience in regulatory affairs for electrical devices and medical devices is a plus.
• In-depth knowledge of regulatory requirements for electrical devices, machinery, and medical devices, as well as international approval requirements, is desired.
• A structured, independent work style and a passion for cross-functional collaboration.
• A pragmatic approach and a strong focus on finding solutions.
• Excellent German and English language skills, additional languages are a plus.

Responsabilités

• Support the implementation of regulatory requirements for electrical equipment (ovens, milling machines, etc.) and share responsibility for creating and maintaining national and international technical documentation.
• Develop regulatory approval strategy in collaboration with Product Development, Sales, and Marketing, and manage deadlines and timelines.
• Coordinate international product registrations—from new registrations and amendments to deregistration—in collaboration with subsidiaries, local partners, and regulatory authorities.
• Support other departments with complaints, Non-Conformities (NCs), and Corrective and Preventive Actions (CAPA).
• Monitor regulatory developments and assess the impact of changes on registrations.
• Work as part of project teams.

Connaissances

German language

English language

Formation

Bachelor’s degree in medical technology or related field

Description du poste

Ivoclar EMEA in Naturno, Italy seeks a regulatory affairs specialist for electrical devices and medical devices to develop regulatory strategies, coordinate international registrations, and manage documentation across the product lifecycle.

You will collaborate with Development, Sales, and Marketing, monitor regulatory changes, support CAPA and NC handling, and ensure timely approvals with a focus on cross-functional teamwork and pragmatic problem solving.