Global Regulatory Affairs Strategy Manager

ZEISS Group; Castiglione Olona; In loco; EUR 30.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading optical technology company in Castiglione Olona is seeking a Global Regulatory Affairs Strategy Manager to lead global regulatory strategies and engage with regulatory authorities. The ideal candidate will have a Bachelor's or Master's degree in relevant fields and over 7 years of experience in Regulatory Affairs within the life sciences or medical industry. This role offers opportunities for professional growth and access to cutting-edge technology.

Servizi

Opportunities for professional growth

Access to cutting-edge technology

Supportive and inclusive work culture

Comprehensive training programs

Competenze

• 7+ years of experience in Regulatory Affairs within life sciences or medical industry.
• Strong understanding of international regulatory frameworks.
• Proven success managing portfolios across multiple projects.

Mansioni

• Lead global regulatory strategies for new business initiatives.
• Coordinate with teams to ensure compliance across markets.
• Engage with regulatory authorities to clarify requirements.

Conoscenze

Regulatory Affairs

Stakeholder engagement

Negotiation skills

Strategic thinking

Analytical skills

Formazione

Bachelor’s or Master’s degree in relevant fields

Descrizione del lavoro

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. With our passion for excellence, we create value for our customers and inspire the world to see in new ways. 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.

Our Benefits

• 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 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.