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Responsibilities:
- 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. Review promotional materials. 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.
- Provide Expertise in Software as a Medical Device (SaMD), MDR, and IVDR and related regulations and guidance documents in U.S., Europe, Canada, and APAC. For example, 21 st 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.
Requirements:
- Degree in engineering or biomedical engineering
- At least 5 years of experience in regulatory affairs working within medical device
- Experience with software, SaMD; working knowledge of software and software development
- Strong understanding of US regulations and FDA
- Profound knowledge of EU guidance documents
- Experience with MDR
- Experience with submissions for US and EU
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