Regulatory Affairs Manager
- Career level: Direct Entry
- Employment: Fulltime, permanent
- Start: 04-02-21
- 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 more than 3,600 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
- 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
- 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.
- Attractive employee benefits
- Attractive performance bonus
We look forward to meet you!
If you have any questions please contact:
Hui Yee Guan, +60 (12) 5173830