Job Details

Assistant General Counsel

Company name

Forte Research Systems

Organization Type

In-House

Job Type

Attorney

Date Last Verified

Jun 21,2019

Valid Through

Oct 04,2019

Posted on

Dec 17,2018

Years of Experience

Min 5 yrs required

Location

Madison, WI, United States

Employment Type

Full-time

Industry

Legal
Practice Area
Corporate >> Corporate - General
Health Care >> Health Care
Labor & Employment >> Labor & Employment
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Assistant General Counsel
The candidate advises on legal issues relating to compliance, regulatory requirements, employment law, and general corporate legal matters. Drafts, reviews, and negotiates customer-facing technology agreements and other customer-oriented agreements including business associate agreements. Oversees formulation of company quality manual, procedures, work instructions and policies. Responsible for maintaining the company’s ISO certification. Serves as the Management Representative, develop and maintain the management review process. Advises senior management and board of directors on policies and practices and serve as expert on all regulatory and quality matters with appropriate updates based on information and data related to Quality, Compliance and Regulatory Affairs. Leads the development and implementation of Firm's Disaster Preparation and Recovery, CAPA, Investigation and Audit Programs. Responsible for compliance with all privacy and confidentiality laws including the Health Insurance Portability & Accountability Act ("HIPAA"). Ensure compliance with applicable State and Federal Laws and Regulations. Implement validation procedures and testing methods. Participate in goal deployment and strategic planning activities, typically detailing first level improvement, initiates and targets to improve.

Qualification and Experience

The candidate must have a law degree (J.D.) from an A.B.A. accredited law school. Should have License to practice law in Wisconsin (or eligibility for admission to the bar). Must have 5+ years of practicing law; in-house experience preferred. Experience with HIPAA compliance and PHI preferred. Must have experience leading and managing Regulatory and Quality departments. Should have experience managing small to medium size teams of highly competent, self-driven professionals. Must have experience working in a software product-based company or software development environment. Should have strong knowledge of ISO certification, quality management systems and quality system standards, including ISO quality standards, medical device regulations (ISO 13485, FDA QSR, MDD etc.) and related standards. Should have excellent analytical and problem-solving skills. Must be able to exercise common sense to provide both practical and theoretical advice; must be a creative problem solver and have good business instincts. Should have knowledge of regulations and guidelines related to the clinical research as well as software services environment. Must have demonstrated success integrating compliance into daily business operations. Should have demonstrated ability to act as an ambassador for continuous improvement. Must have superior communication skills (written, oral, presentation, and instructional) and ability to effectively interact with customers, dealers, suppliers, team leaders, managers, associates, and executives. Must have clear, concise and persuasive writing and presentation skills.

Company info

Hiring Coordinator
Forte Research Systems
1200 John Q Hammons Dr., Suite 300
Madison, WI 53717

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