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

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.

Apply now