Global Regulatory Affairs Manager, Medical Devices (Hybrid)

Zeiss Group; Setúbal; Híbrido; EUR 60 000 - 90 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

Meal allowance

Flexible benefits

28 vacation days

Lens discounts

Wellbeing programmes

Hybrid work model

Global travel

Resumo da oferta

ZEISS in Lisbon, Portugal, seeks a Regulatory Affairs Manager to lead regulatory activities for the XRX Strategic Business Unit. You will coordinate registrations, ensure EU MDR and FDA compliance, and work with international teams to deliver innovative products.

Requires 3+ years in regulatory affairs for medical devices, a related degree, strong MS Office skills, and fluent English. Hybrid work model with international travel.

Qualificações

• Bachelor's or Master's degree in Engineering, Life Sciences, Regulatory Affairs, Quality Management, or related.
• Minimum 3 years' experience in Regulatory Affairs within the medical device industry.
• Experience managing product registrations across multiple international markets.
• Experience with FDA 510(k) submissions and FDA audits.
• Experience with EU MDR 2017/745 and ISO 13485.
• Strong knowledge of regulatory requirements for EU/US markets.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint).
• Fluent in English (written and spoken).

Responsabilidades

• Lead and coordinate regulatory affairs activities within the XRX SBU.
• Act as the interface between XRX and VIS Global Regulatory Affairs.
• Develop and execute the XRX regulatory strategy for registrations.
• Monitor evolving regulatory requirements and provide guidance.
• Lead product registrations, submissions, and documentation reviews.
• Ensure compliance with EU MDR, FDA, MDSAP, and international standards.
• Support post‑market surveillance and CAPA follow‑ups.
• Serve as main regulatory contact for customers, authorities, and audits.
• Collaborate with internal teams and external stakeholders.

Conhecimentos

Regulatory Affairs

510(k)

EU MDR

ISO 13485

MS Office

English

Formação académica

Bachelor's or Master's degree in Engineering

Bachelor's or Master's in Life Sciences

Regulatory Affairs or Quality Management

Ferramentas

Power BI

SharePoint

Descrição da oferta de emprego

ZEISS in Lisbon, Portugal, seeks a Regulatory Affairs Manager to lead regulatory activities for the XRX Strategic Business Unit. You will coordinate registrations, ensure EU MDR and FDA compliance, and work with international teams to deliver innovative products.

Requires 3+ years in regulatory affairs for medical devices, a related degree, strong MS Office skills, and fluent English. Hybrid work model with international travel.