Global Regulatory Affairs Strategy Manager

Overview

Job title: Global Regulatory Affairs Strategy Manager - New Business

Location: Castiglione Olona, Province of Varese, Italy

Contract: Full Time

Salary: [To be defined based on experience]

ZEISS is technology and innovation. Founded in Germany in 1846, we’re an internationally leading technology enterprise operating in the optics and optoelectronics industries, generating more than €10.8 billion in revenue with around 46,000 employees across 50 countries. As a company wholly owned by a foundation, ZEISS is rooted in and committed to responsibility in all its activities. We invest approximately 15% of revenue in science and R&D. As the pioneer of scientific optics, we continue to challenge the limits of human imagination. We’re looking for a Global Regulatory Affairs Strategy Manager - New Business to join us in Castiglione Olona.

Your Role

As a Global Regulatory Affairs Strategy Manager, you will:

• Lead and implement global regulatory strategies that align with new business initiatives in the vision care sector.
• Coordinate with global cross-functional teams and external stakeholders to ensure compliance across markets.
• Anticipate and adapt to evolving regulatory landscapes to support strategic business goals.
• Develop proactive approaches to regulatory submissions, authorizations, and lifecycle management.
• Engage directly with regulatory authorities to clarify and influence regulatory requirements.
• Guide internal teams (e.g., R&D, Clinical, Quality, Marketing) with strategic regulatory input.
• Support M&A due diligence processes through regulatory assessments.
• Deliver internal training on regulatory trends and process optimization.

Your Experience

As a Global Regulatory Affairs Strategy Manager, you will have:

• A Bachelor’s or Master’s degree in Regulatory Affairs, Life Sciences, Medical Industry, Law, IT, or related disciplines.
• 7+ years of experience in Regulatory Affairs within the life sciences or medical industry.
• Strong understanding of international regulatory frameworks (e.g. FDA, MDR, ISO 13485, MDSAP).
• Proven success managing portfolios across multiple projects and geographies.
• Effective communication, stakeholder engagement, and negotiation skills.

You will ideally have

• Experience in developing innovative regulatory strategies that create competitive advantage.
• Strategic thinking with strong analytical and problem-solving abilities.
• Demonstrated resilience and drive to achieve complex goals.
• Experience working with global regulatory bodies (e.g., FDA, EMA, PMDA, NMPA, Notified Bodies).
• Proficiency in English; additional languages are a plus.

Benefits and Culture

• Opportunities for professional growth and international collaboration
• Access to cutting-edge technology and world-class facilities
• Supportive and inclusive work culture
• Comprehensive training and development programs

Diversity

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.

Seniority level

• Associate

Employment type

• Full-time

Job function

• Strategy/Planning and Product Management

Industries

• Medical Equipment Manufacturing

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