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Regulatory Affairs Specialist II

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Position Role/Tile: Regulatory Affairs Specialist II

Duties 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
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.
Expertise in Software as a Medical Device (SaMD) 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.
Skills Typically, a minimum of 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

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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