Global Regulatory Affairs Strategy Manager

Global Regulatory Affairs Strategy Manager - Frames

Italy - Remote

Full Time

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 Euros in revenue with around 46,000 employees across 50 countries around the globe.

As a company wholly owned by a foundation, ZEISS is rooted in and committed to responsibility in all its activities. Therefore, 15% of revenue is currently invested 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 Manager to join us in Italy.

Your Role

• Develop global regulatory strategies for Frames Business initiatives taking into account international requirements (e.g. FDA, MDR, IVDR, NMPA, PMDA). Coordinate with external parties and stakeholders to ensure new business initiatives meet all regulatory requirements in diverse markets. Regularly adapt regulatory strategies to support strategic decisions and respond flexibly to changes in the regulatory landscape.
• Proactively identify regulatory opportunities and risks and derive actions to optimise market authorisation and product lifecycles.
• Early assessment and interpretation of regulatory requirements in different markets to develop innovative solutions and create competitive advantage.
• Provide strategic advice to internal teams (e.g. R&D, Clinical, Quality, Marketing) to optimise regulatory strategies.
• Preparation and review of regulatory documentation for global submissions and fast-track applications
• Proactive communication with regulatory authorities (e.g. FDA, EMA, BfArM, Notified Bodies) to gain early clarity on regulatory requirements
• Monitor regulatory trends and changes, derive early adaptation strategies and actively shape regulatory developments in relevant committees.
• Ensuring global regulatory compliance for new business initiatives
• Proactive support of due diligence processes and regulatory assessments in the context of M&A projects
• Training internal teams to anticipate regulatory requirements and design efficient processes

Your Experience

• In-depth knowledge of international regulatory requirements (e.g. FDA, MDR, ISO 13485, MDSAP, etc.) and experience in developing proactive regulatory strategies and interacting with authorities.
• Portfolio management: Experience in managing several parallel projects across geographies and functional areas.
• Communication, negotiation, collaboration and stakeholder engagement
• Strategic thinking with analytical skills and strong problem-solving skills Ability to structure complex projects and drive change management
• Personal drive and resilience to achieve successful outcomes
• Languages: Proficiency in English; additional languages are an advantage.

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.