Hiring Organization / Company: Roche
Basic Salary: To Be Discussed
Employement Type: Full-Time
- Responsibilities associated with the development, support, and deployment of the Company’s non-medical and medical device software products.
- 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.
- 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.
- Familiar with 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 Regulations (MDR), EU guidance documents, IEC 62304, ISO 13485, ISO 14971, AAMI TIR45, AGILE development, etc.
- Supports global regulatory initiatives and collaborates with quality and regulatory professionals across the Roche organization.
- Bachelor’s degree or equivalent
- Typically, at least 2 years of related Regulatory Affairs experience
- Working knowledge of software and software development
- Excellent oral and written communication skills
- Consistently neat and accurate reporting
- High attention to detail
- Excellent organizational skills
- Proficient in MS Office applications
- Excellent people skills: tact, collaborative, able to communicate with personnel at various levels in the organization
- Class I, II and III medical device experience
Job Location Information:
City: Santa Clara
Location: Santa Clara, Ca 95050
Date Posted: 2021-05-14
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