Regulatory Affairs Specialist - Medical Devices

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 is technology and innovation. Founded in Germany in 1846, ZEISS is an internationally leading technology enterprise operating in the optics and optoelectronics industries across 50 countries.

As a company wholly owned by a foundation, ZEISS is committed to responsibility in all its activities. As a pioneer in scientific optics, its employees across the globe continue to push the boundaries of what is possible. With a strong focus on quality and innovation, ZEISS creates value for its customers and helps shape new ways of seeing the world.

We're looking for a Regulatory Affairs Manager to join us in Lisbon, Portugal, supporting the continued growth and innovation of our global XRX business.

Carl Zeiss Vision Portugal (Global Lisbon Hub) is part of the ZEISS global network, bringing together expertise and innovation to support the development of advanced technology solutions. In this role, you will help ensure regulatory excellence across global markets, working with international teams to enable the successful delivery of innovative products.

Your Role

As Regulatory Affairs Manager, you will lead and coordinate regulatory affairs activities within the XRX Strategic Business Unit. Acting as the key interface between XRX and the VIS Global Regulatory Affairs team, you will ensure that products comply with applicable regulatory requirements and standards across global markets.

You will develop and execute the XRX Regulatory Affairs strategy, support product registrations for open market and custom solutions projects, monitor evolving regulatory requirements, and provide regulatory expertise to internal teams, customers, and external stakeholders.

The role of Regulatory Affairs Manager will involve:

• Developing and maintaining the XRX Regulatory Affairs strategy in alignment with ZEISS objectives and global regulatory requirements.
• Coordinating regulatory activities with the VIS Global Regulatory Affairs team for open market and custom solutions projects.
• Defining regulatory requirements, registration pathways, and strategies for new product developments.
• Leading product registrations, regulatory submissions, and regulatory documentation reviews.
• Ensuring compliance with applicable regulatory frameworks, including EU MDR (2017/745), FDA requirements (including 510(k) submissions), MDSAP, and relevant international standards.
• Monitoring global regulatory developments related to AR/VR and Smart Glasses technologies and assessing their impact on the XRX product portfolio.
• Providing regulatory guidance and consultation to internal stakeholders throughout product development and lifecycle management.
• Acting as the main regulatory contact for customers, expert discussions, regulatory authorities, and audit activities.
• Supporting post‑market surveillance activities, regulatory communications, audit preparation, and follow‑up of corrective and preventive actions (CAPAs).

Your Experience

• Holding a Bachelor's or Master's degree in Engineering, Life Sciences, Regulatory Affairs, Quality Management, or a related discipline.
• Bringing a minimum of 3 years' experience in Regulatory Affairs within the medical device or medical technology industry.
• Demonstrating proven experience managing product registration processes across multiple international markets.
• Having experience with FDA regulatory requirements, including successful 510(k) submissions and FDA audits.
• Having experience working with the European Medical Device Regulation (EU MDR 2017/745) and ISO 13485.
• Possessing strong knowledge of regulatory requirements and standards, particularly for EU and US markets.
• Demonstrating good proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint.
• Being fluent in English, both written and spoken.

It would be desirable if you had:

• Experience with MDSAP requirements and additional regulatory frameworks such as NMPA, PMDA, TFDA, or TGA.
• Familiarity with standards including ISO 14971 (Risk Management), IEC 62366 (Usability), ISO 10993 (Biosafety), ISO 20417 (Post‑Market Information), and ISO TR 20416 (Post‑Market Surveillance).
• Knowledge of cybersecurity regulations applicable to medical devices, including the AI Act and Cyber Security Act.
• Familiarity with IEC 60601 electrical safety requirements for medical devices.
• Experience with AR/VR or Smart Glasses regulatory landscapes.
• Experience using Power BI and SharePoint.

If you join ZEISS, you will have access to a range of benefits, including:

• Health insurance and life insurance coverage.
• Meal allowance of €10.20 per working day.
• Annual flexible benefits allowance, giving you the freedom to choose how to use it based on your personal needs, including options such as gym memberships, health expenses, and public transport.
• 28 vacation days to support work‑life balance and personal wellbeing.
• ZEISS lens discounts for employees and their direct family members.
• Wellbeing programmes supporting employees and their families through flexible solutions and access to free annual appointments across different areas, including legal support, psychological wellbeing, nutrition, and other wellbeing pillars.
• Role location: Lisbon, Portugal - This role follows a hybrid working model, with 2 days working from the office and 3 days working remotely from home.
• Global travel is expected as part of the role, supporting collaboration with international teams, customers, regulatory partners, and stakeholders across different markets.