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Life Scientist, Medical Scientist, Medical Engineer as Regulatory Affairs Manager - IVD Hardware / Software, Medical Devices (m/f/d)
We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world.
That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.
We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world.
We are Roche.
Regulatory Affairs Manager IVD Hardware/Software
This Regulatory Affairs Function is responsible for the overall development, implementation and coordination of regulatory strategies and activities. To strengthen the team we are looking for a Regulatory Affairs Manager. The Rotkreuz department is responsible for requirements related to platforms developed with internal and external partners.
- Providing support to currently marketed products, managing the regulatory activities and supporting the product care activities of the assigned product portfolio e.g. review changes, labeling, promotional material, product changes and documentation for compliance on own authority
- Maintaining product technical files and managing ongoing activities related to compliance with Global Regulatory directives and regulations. Accomplishing conformity evaluation for new and existing products
- Assessing and reporting on product specific regulatory issues that may have impact on the business units, the corporation, or the customer
- Assessing, consulting and actively supporting on new product development, product life cycle and regulatory risks with the R&D project teams, lifecycle team or Quality department
- Educating and training the organization on regulatory topics
- Planning of Deliverables for product registrations, including compilation of corresponding Software- and Hardware-Reports and ensuring product approvals/clearances with other Regulatory Affairs professionals in the various regions (USA, Canada, China, etc.)
Who you are
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.
- You possess a degree in Science, Engineering, or related technical field
- You hold professional experience in Regulatory Submissions and Project Support, preferably in the area of regulated instrument and software development
- You are experienced in the regulatory framework in Medical Devices with ideally good know-how of IVD/Medical Devices Directives and Software Development within international regulations for IVD devices and the related international registrations
- Ideally, you gained experience in the area of technical product compliance (product safety, RoHS Directive, Electromagnetic Compatibility Directive, Low Voltage Directive and Machinery Directive) an the related conformity assessment procedures
- You gained knowledge of design control requirements for In-Vitro Diagnostic (Software, instruments, analytical systems and solutions)
- You supported product development teams for the implementation of regulatory requirements in the technical product development and supported the registrations
- You are familiar with systematically monitoring changes to regulatory requirements and standard updates and are motivated to work in committees to contribute to their updates
- Proficient presenter and negotiator in written and spoken English (German language skills are beneficial)
While applying for the job please refer to jobvector and use the following reference number:
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