Senior Manager Regulatory Intelligence & Advocacy EMEA (m/w/x)

Aalen - Germany

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

The job posting is outdated and position may be filled

Job Summary

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 fromtailored lenses to award-winning measurement 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

Bachelors 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

Required Experience:

Senior Manager

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 fromtailored len...