Job Information
Sartorius Lead Regulation & Standards Professional in Bangalore, India
The responsibilities of this position include identifying, evaluating and implementing regulatory requirements and industry guidelines as well as designing related business processes for our software products. Shape the future with us.
The responsibilities of this position include identifying, evaluating and implementing regulatory requirements and industry guidelines as well as designing related business processes for our software products. Shape the future with us.
Responsibilities and duties:
Conduct comprehensive assessments of regulatory requirements, technical standards, and industry guidelines that are pertinent to the development and lifecycle management of software products within the Digital Solutions division
Proactively identify and evaluate the impact of regulatory requirements, cybersecurity standards, and industry guidelines on the development and maintenance of our software products tailored for the biopharmaceutical industry
Develop and maintain procedural definitions that facilitate the effective management of software products in compliance with regulatory requirements and technical standards, including GMP and cybersecurity standards (e.g., IEC 62443)
Provide expert advice and support to our software development teams, ensuring adherence to relevant regulatory frameworks, standards, and industry guidelines, such as 21 CFR Part 11, EU Cyber Resilience Act, GAMP 5, and other region-specific regulations
Engage in proactive collaboration with key stakeholders, including product development and product management teams, to streamline our process landscape for enhanced efficiency
Design and deliver educational programs to train stakeholders on the established processes, ensuring a comprehensive understanding and implementation of compliance measures
Your qualifications
You have a university degree in biotechnology or comparable technical or scientific disciplines
You have in-depth knowledge and at least 10 years of experience in regulatory requirements and cybersecurity standards for the usage and implementation of software products in biopharmaceutical environments – in particular 21 CFR Part 11, EU GMP Annex 11, GCP, IEC 62443
You have experience in the definition and application of business processes in the field of software development
Knowledge of agile software development methods is desirable
You are fluent in written and spoken English
Ability to work in a team, communication skills, a structured way of working and an analytical approach round off your profile
You identify with our values of sustainability, openness and joy and are motivated to work in a fast-growing company
About Sartorius
Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.
Join our global team and become part of the solution. We are looking forward to receiving your application. www.sartorius.com/careers
to our Candidate Portal and thank you for your interest in working and growing with us. We look forward to receiving your application. You can check the status anytime in this portal.
Here you will find the best application tips from our HR team.
Information on the application process can also be found in this video and under FAQ & Contact (https://www.sartorius.com/en/company/careers/faq) .
In this brochure (https://www.sartorius.com/resource/static/celum/202114/23_EN_Candidate_Booklet_Digital_web.pdf) you will learn more about us as an employer and your career with us. For further insights, please visit the Sartorius Blog (http://www.sartorius.com/en/company/newsroom/blog) and our career website (http://www.sartorius.com/en/company/careers) .
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