Regulatory Affairs Specialist - MDR

ZEISS Group; Castiglione Olona; Ibrido; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading technology and innovation firm in Lombardy is seeking a Regulatory Affairs Specialist to ensure compliance with regulatory requirements for medical devices. This role offers a hybrid working model and is ideal for candidates with a background in regulatory affairs, particularly within the medical device sector. The successful candidate will liaise with cross-functional teams to support product registration and compliance while contributing to new product launches.

Servizi

Hybrid working model

Bonus

Work within a diverse team

Competenze

• 1–2 years of experience in Regulatory Affairs within the medical device sector.
• Solid knowledge of MDR (EU) 2017/745, ISO 13485, and ISO 9001 standards.

Mansioni

• Prepare, manage, and maintain regulatory documentation.
• Monitor and interpret evolving regulatory requirements.
• Collaborate cross-functionally to ensure regulatory compliance.
• Support post-market surveillance and reporting.
• Participate in internal training sessions.

Conoscenze

Detail-oriented

Organizational skills

Communication skills

Fluency in Italian

Fluency in English

Formazione

University degree in a science-related field

Descrizione del lavoro

Overview

Regulatory Affairs Specialist

3 days on-site, 2 days smart working

Permanent Contract

ZEISS is technology and innovation.

ZEISS Vision Care Italy is dedicated to supporting opticians with high-precision ophthalmic lenses and tailored eyewear solutions. Although lenses are manufactured across ZEISS global facilities, the Italian site specializes in processing, assembling, and tinting lenses—delivering premium-quality eyewear customized for the local market. With around 420 employees, we operate exclusively in Italy and pride ourselves on a close-knit, innovative, and collaborative culture.

Your Role

As a Regulatory Affairs Specialist, you will play a key role in ensuring our medical device products meet regulatory requirements in line with MDR (EU) 2017/745, Italian regulations, and relevant quality standards. This position is ideal for someone at the early stages of their career in Regulatory Affairs, who is looking to build expertise within a growing and supportive environment.

You will:

• Prepare, manage, and maintain regulatory documentation to support product registration and approval.
• Monitor and interpret evolving regulatory requirements and advise internal stakeholders accordingly.
• Collaborate cross-functionally with Product Management, Supply Chain, Legal, and Global RA teams to ensure regulatory compliance throughout the product lifecycle.
• Support post-market surveillance and reporting to ensure product safety and efficacy.
• Participate in internal training sessions and help create presentations and documentation for regulatory updates.
• Actively contribute to the launch of new products from a regulatory standpoint.

Your Experience

To succeed in this role, you’ll bring:

• A university degree in a science-related field.
• 1–2 years of experience in Regulatory Affairs within the medical device sector.
• Solid knowledge of MDR (EU) 2017/745, ISO 13485, and ISO 9001 standards.
• A detail-oriented mindset with strong organizational and communication skills.
• Fluency in Italian and English (essential).

It would be great if you also have:

• Familiarity with ophthalmic products or the vision care sector.
• Experience with Root Cause Analysis and CAPA methodologies.
• A proactive approach and the confidence to work independently while collaborating across teams.
• A desire to grow your regulatory career in a structured yet flexible role with long-term potential.
• Salary aligned to market conditions
• Hybrid working: Onboarding will be primarily on-site, followed by a flexible model (3 days onsite, 2 days smart working).
• Bonus
• Work within a diverse and collaborative team in a growing regulatory function.
• Gain exposure to global and local stakeholders and projects.
• Develop your skills in a newly created role designed to evolve with your experience.

Apply now to take the next step in joining ZEISS, where you can push technological boundaries, shape markets, and contribute to the advancement of society.

Diversity is a part of ZEISS.

We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, ideology, disability, age, or sexual orientation and identity.

Details

• Seniority level: Associate
• Employment type: Full-time
• Job function: Legal, Product Management, and Manufacturing
• Industries: Machinery Manufacturing

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