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

Carl Zeiss Vision International GmbH; Aalen; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading company in vision care is seeking a Senior Manager for Regulatory Intelligence & Advocacy EMEA in Aalen. The role involves tracking and analyzing regulatory changes, developing compliance strategies, and representing the company in industry forums. Candidates should have a degree in Life Sciences, substantial experience in Regulatory Affairs, and proficiency in German and English. This position offers opportunities for professional growth in a collaborative environment.

Qualifikationen

• Profound experience in Regulatory Affairs within the Life Sciences or Medical industry.
• Strong understanding of regulatory requirements including FDA, MDR, ISO 13485.
• Ability to manage multiple projects across geographies.

Aufgaben

• Track and analyze regulatory changes in EMEA markets.
• Maintain a regulatory intelligence database.
• Develop regulatory framework strategies for Vision.

Kenntnisse

Regulatory Affairs expertise

Project management

Communication skills

Problem-solving

Digital tools proficiency

Multilingual proficiency

Ausbildung

Bachelor's degree in Life Sciences or related field

Advanced degree (MSc, MBA) or RAC certification preferred

Jobbeschreibung

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

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

Apply locations Aalen time type Full time posted on Posted Yesterday job requisition id JR_1043139

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 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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Step out of your comfort zone, excel and redefine the limits of what is possible. That’s just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people.

In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together.

Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.

Apply now! It takes less than 10 minutes.