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Senior manager regulatory intelligence & advocacy emea (m/w/x)

Aalen
Confidential
Senior Manager
Inserat online seit: Veröffentlicht vor 21 Std.
Beschreibung

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.

Join us today. Inspire people tomorrow.

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.
* 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


* 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


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