Regulatory Affairs Manager
Job-Fakten Who We Are
Roche Diagnostics International Ltd in Rotkreuz is one of the world's leading providers of diagnostic system solutions for clinics, laboratories and doctors' offices. The company employs over 2200 people in Rotkreuz and is one of Roche Diagnostics main sites.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law. The Position
This Regulatory Affairs function belongs to the Roche Centralised and Point of Care Solutions (CPS) business area and supports the instrument and systems projects and the related product portfolio.
This role is responsible for the overall development, implementation and coordination of regulatory strategies and activities with focus on analyzer and software products and projects. The Rotkreuz department is responsible for requirements related to platforms developed with internal and external partners.
The advertised position offers:
Who you are
- Manages the regulatory activities and supports the product care activities of the assigned product portfolio within Centralised and Point of Care Solutions (CPS)
- Assesses and communicates regulatory risks and challenges to project teams and interfaces with the lifecycle team
- Consultancy and active support of the R&D project teams during the development of new products and during the product lifecycle
- Accomplishes conformity evaluation for new and existing products
- Planning of Deliverables with other Regulatory Affairs professionals (USA, Canada, China etc.) for product registrations, including compilation of corresponding Software- and Hardware-Reports
- Ensures the interface between Roche (Rotkreuz) and Regulatory Affairs teams for product approvals/clearances in the various regions (USA, Canada, China, etc.)
- Works in a cross-functional, multi-site team to ensure alignment and harmonization
You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
To be successful in this role you will have at minimum a degree in e.g. IT, Engineering or Natural Sciences with further education in Regulatory Affairs, and you
- bring along 3-5 years of experience in Regulatory Submissions and Project Support, preferably in the area of regulated analyzers and software development
- are experienced in the regulatory framework for IVD Medical Devices and/or Medical Devices with good know-how of IVDD/VDR and international regulations for IVD devices
- gained knowledge of design control requirements for In-Vitro Diagnostic (Software, instruments, analytical systems and solutions)
- are able to think strategically and set concrete objectives
- are a proficient presenter and negotiator (fluently in English and preferably also in German)
- call yourself a strong team player with resilience and high self-esteem
- like to travel in EU and overseas to support international project teams
- Wer wir sind Roche Diagnostics International Ltd in Rotkreuz is one of the world's leading providers of diagnostic system solutions for clinics, laboratories and doctors' offices. The company employs over 2200 people in Rotkreuz and is one of Roche Diagnostics' main sites. Read more .
Roche is an equal opportunity employer.