J. Teresa Dorriety

Experience in advising healthcare and juvenile products manufacturers on requirements for distribution of products in the US and Canada. Created recall management program to effectively address product noncompliance from investigation to consumer notice, while meeting expectations of federal agencies and safety advocates. Develop and conduct risk management training programs.

Legal and Regulatory professional with extensive experience advising healthcare manufacturing companies in the requirements for distribution of medical devices in the US and worldwide. Develop annual training programs to meet needs of in-house and field personnel. Manage quality systems in compliance with US FDA regulations - including corrective / preventive action programs, internal audits, complaint handling, performance tracking, and management reviews.

Develops compliance and ethics programs in corporate and higher education environments. Creates compliance and ethics procedures with training materials, for interacting with healthcare professionals, to ensure compliance to anti-bribery laws.

Reviews, drafts and negotiates various types of agreements including vendor, retailer, and hotel agreements. Advise at all levels of the negotiation process from Request for Proposal through execution. Evaluates and tracks contract compliance.