Regulatory Affairs Manager

Would you like to work for a company who has made it its mission to make a contribution to improving human living conditions? With around 4,500 employees worldwide Eppendorf is a leading Life Sciences company. We develop and distribute devices, consumables and services for use in laboratories worldwide. Our daily work is characterized by our principle: Collaborate on new ideas. You would like to take responsibility and help to make a difference in an experienced international company? Exciting tasks combined with a positive and affirmative working environment await you at Eppendorf. You are also motivated by technical challenges? Then apply now!

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Your challenges

Quality Management

• Responsible for implementing and maintaining the effectiveness of the quality management system according to ISO 9001, 17025.
• Being the representative of the Quality Department towards external Authority inspections and client audits.
• Proactively provides leadership in Quality System definition and deployment with focus on prevention, continuous improvement programs, and customer satisfaction.
• Provide quality and process related training.
• Conduct Internal Audits as well as external Audits, e.g. at suppliers, distributors.
• Establish and monitor KPI performance including data collection and providing reports to the management.

Regulatory Affairs

• Evaluate national requirements.
• Compile, prepare, review and submit regulatory submissions to authorities in cooperation with EAG and Competence Center Regulatory Affairs colleagues.
• Monitor validity of licenses, registrations and listings and renew in time.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle.
• Support/consult local organizations

Your expertise

• Bachelor’s Degree in Science or related discipline.
• Deep knowledge in Q-Systems ISO 9001, 17025.
• Deep knowledge in Regulatory Submission processes within APA Region.
• At least 5 years of experience in the Life Science or Medical Device industry.
• Excellent English language and communication skills.
• Additional language skills related to the markets desirable.
• Strong intercultural competence and experience in working with Asian and European/Western organizations.
• Experience in cross functional working in a matrix organization.
• Understanding the market and customer needs is mandatory to provide efficient solutions.
• Building a new Quality Management and Regulatory Affairs department as short-term strategy requires a strong contribution and driven by him/herself.
• Being responsible for the Asia Pacific India & MEA region a strong internal and external customer focus is needed to ensure pragmatic and smooth Quality Management and Regulatory Affairs solutions.

Your benefits at Eppendorf

• We truly appreciate our employees and their performance. This is why we offer an attractive salary.
• By working with us, you will make a meaningful contribution to improving human living conditions.
• To enable you to depend your technical knowledge and to continuous development, we offer a wide range of training and development options.

Please note that we can only consider applications that are submitted online via our application management tool.

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