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Food & Drug Administration,Health Care/Attorney/In House/Deerfield, Illinois

Company Name:
BITSOFT INTERNATIONAL, INC.
Senior Attorney Regulatory Law
The candidate advises the Company and its subsidiaries on FDA (and international counterparts) laws, regulations and guidance documents with respect to complex regulatory issues relating to promotion, advertising, marketing and labeling of products sold at retail, as well as general regulatory advice on a variety of complex regulatory issues affecting product in the global marketplace. Represents the Company before federal, state, local regulatory agencies, as well as global agencies, on legal matters related to regulatory law and practice, with focus on FDA matters. Provides regulatory support to firm?s Product Integrity/Quality Assurance business team for various regulations affecting business operations. Provides legal review, advice, and counsel regarding product labels, advertising and marketing materials, and on new business initiatives envisioned and/or affected by regulations; federal, state or international. Advise on a variety of specialized global regulatory issues, including FCPA, AML, global product placement and procurement, and product safety issues. Assists in development of risk management review for business teams. Performs Medical Device Establishment registration for firm?s private brand products. Work with or provide work direction and counsel to other attorneys and support team members in the Legal Division. Handling other regulatory matters and special projects as assigned.

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