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Regulatory Affairs Specialist II

Santa Clara, CA
Position Role/Tile: Regulatory Affairs Specialist II
Location: Santa Clara, CA.

• 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.
• 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.  

Minimum Qualifications:
• Bachelor's degree or equivalent
• Master's degree/PhD. or equivalent (preferred)
• Typically, a minimum of 6+ 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

Preferred Qualifications:
• US FDA Class I, II and III medical device experience
• EU MDD experience

Central Business Solutions, Inc,
37600 Central Ct.
Suite #214
Newark, CA 94560
Central Business Solutions, Inc(A Certified Minority Owned Organization)
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Central Business Solutions, Inc
37600 Central Court Suite 214 Newark CA, 94560
Phone: (833)247-8800 Fax: (510)-740-3677
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