Aalen, Germany
11 hours ago
Senior Manager Regulatory Intelligence & Advocacy EMEA (m/w/x)

Your Talent, our Vision – together we see beyond. Your start at ZEISS Vision Care. As a leading manufacturer of ophthalmic lenses, we help people around the world achieve a clearer vision – sustainable and with focus on the future. 

Our products are as diverse as the career paths we offer, from tailored lenses to award-winning measurement systems. Become part of our team and shape a future in which clear vision and professional success go hand in hand.

Your Role

Track and analyze regulatory changes, guidelines, and policy trends in key EMEA markets (e.g., EU, MOEL, SEE, META) to stay informed and proactive

Identify and assess new and evolving requirements for the Vision Care Portfolio, supporting the development of innovative solutions and competitive advantages

Maintain a regulatory intelligence database and provide timely updates to internal teams to ensure alignment with current regulations

Develop EMEA regulatory framework strategies for Vision to ensure compliance with regulatory requirements for Quality Management Systems (QMS) and products

Represent the company in EMEA industry associations and regulatory forums, building relationships with key regulators and policymakers

Prepare position papers and execute advocacy strategies to influence regulatory policies in alignment with business objectives, while identifying regulatory opportunities and risks

Conduct training for internal teams to anticipate regulatory requirements, develop clear summaries of complex regulatory issues, and create trend reports for upcoming challenges

Your Profile

Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs or related fields; advanced degree (MSc, MBA) or RAC (Devices) certification preferred

Profound experience in Regulatory Affairs within the Life Sciences or Medical industry, with a strong understanding regulatory requirements (e.g., FDA, MDR, ISO 13485, MDSAP) as well as EMEA regulatory frameworks and strategies (e.g. EU MDR)

Proven knowledge in managing multiple parallel projects across geographies and functional areas including the interaction with authorities and external stakeholders with strong communication, negotiation, and collaboration skills

Proficiency to leverage digital tools and platforms to enhance regulatory processes and communication

Ability to think strategically with analytical skills and strong problem-solving capabilities to navigate complex regulatory challenges in a multicultural environment

Proficiency in German and English; additional languages are an advantage

Your ZEISS Recruiting Team:

Hannah Beutler
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