Regulatory Affairs Manager
- Career level: Direct Entry
- Employment: Fulltime, permanent
- Start: immediately
- Location: Chennai
- Job-ID: R659
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!Apply now
- 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.
- 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
- 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.Apply now
We look forward to meet you!
If you have any questions please contact:
Hui Yee Guan,