Tasks & Responsibilities: 

• Definition of technical requirements for diagnostic instruments based on business and customer inputs, risk ratings and context according to internal Roche guidelines

• Knowledge in definition of requirements using EARS (Easy Approach to Requirements Syntax)

• Contribution to the development of requirement engineering concepts and strategies for software and hardware on different levels

• Review of requirements and specifications

• Collaboration within the interdisciplinary development team

• Status reporting to respective project or product leader
   

Key Requirements 

• 5+ years of experience working across full product development lifecycles with focus on requirements engineering 

• Background in regulated environments, ideally within IVD or medical device developmen

• Strong requirements engineering experience, including ALM tools and requirement breakdown/structuring

• Certifications such as CPRE/IREB, CCBA/IIBA, or INCOSE are advantageous

• Experience with requirement analysis, test case creation, test execution, and defect lifecycle management 

• Understanding of the V-model

• Strong analytical thinking, problem-solving, and ability to balance big-picture and detail-oriented work

• Experience moderating and collaborating with multidisciplinary stakeholders and teams

• Strong communication skills, autonomous working style, and pragmatic mindset 

• Fluent English and German are required

Its an urgent role and we have a deadline to submit the candidates by 2nd June 2:00 pm. So if you are interested apply soon or can send me your application directly at richa.bali@randstaddigital.com.