Regulatory Affairs Manager
vor 9 Stunden
**Beschreibung**:
For our international partner, Roche Diagnostics International Ltd. based in Rotkreuz, we are looking for a qualified and motivated **Regulatory Affairs Manager** for one year with option for extension.
This Regulatory Affairs function belongs to the Roche Information Solutions (RIS) business. As Regulatory Affairs they support regulated (medical device) and non-regulated stand-alone software product portfolio. This role is responsible for activities associated with regulatory approval or launch of regulated (medical device) and non-regulated software including the overall development, implementation and coordination of regulatory strategies and activities. Responsible for assessment of device changes for regulatory implications.
**Tasks**:
- Manages regulatory responsibilities associated with the development, support, and deployment of the Company’s non-medical and medical device software products
- Manages development and implementation of regulatory strategies and plans to support the timely introduction of new products and the possible preparation and review of government submissions to achieve timely and cost effective clearance/approval. Provides information for maintaining registrations and listings
- Monitors and assesses domestic and international Regulatory developments (e.g. Federal Register publication/notices, FDA and EU guidelines, etc.) related to the Company’s products
- Reviews product labeling to ensure conformance with applicable regulatory requirements and/or approved product claims
- May serve as a contact with affiliates to achieve international registration of products
- Frequent contact with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects
- Supports global regulatory initiatives and collaborates with quality and regulatory professionals across the Roche organization
- Expertise in Software as a Medical Device (SaMD) and related regulations and guidance documents in U.S., Europe, Canada, and APAC. For example, 21st Century Cures Act and related FDA guidance documents, Medical Device Regulation (MDR), EU guidance documents, IEC 62304, ISO 13485, ISO 14971, AAMI TIR45, AGILE development, etc.
**Must Haves**:
- Min. Master's degree
- Min. 3 to 4 years experience in a similar role
- Experience with MDR
- Experience with US regulations and FDA
- Experience with submissions
- Excellent oral and written communication skills in English
- Consistently neat and accurate reporting
- High attention to detail
- Excellent organizational skills
- Excellent people skills: tact, collaborative, able to communicate with personnel at various levels in the organization
- Experience with software, SaMD; working knowledge of software and software development is a plus
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