SUMMARY

• Passionate compliance expert wif over 15 years of experience. Interpret and provide guidance on requirements.
• Independent project manager leading teams to solve complex problems. Innovative process improvement expertise.
• Proven capability to develop policies, processes, procedures and tools.
• Lead and support investigations, critiques, causal analysis and corrective action development. Mature and implement programs to increase employee awareness.

PROFESSIONAL EXPERIENCE

Regulatory Compliance Specialist

Confidential

Responsibilities:

• Assurance, Assessments, and Corrective Action Management Program Sandia National Laboratories
• Subject Matter Expert for Sandia's execution of Department of Energy (DOE) Order 232.2 Occurrence Reporting and Processing of Operations Information. Interpret requirements and guide Sandia management wif respect to actions that could adversely effect: public or worker health and safety, teh environment, national security, facilities, or Sandia's reputation.
• Interpret requirements of regulations and provide guidance to management. Report to and communicate wif Sandia divisions including, management, attorneys, directors, and vice presidents. In addition, communicate wif Lockheed Martin legal staff and DOE oversight personnel.
• Lead Corrective Action Management Program incorporating elements of DOE Guide 414.1 - 5, Corrective Action Program to improve teh execution of Sandia's corrective action program. Apply “feedback and improvement” to address and resolve issues identified by independent oversight.
• Develop and evaluate policies, procedures, and documentation to establish Sandia's implementation of DOE directives. Identify need to revise training materials and documentation.
• Identify risk associated wif compliance program. Implement systems to empower Sandia to manage Environmental, Quality, and Health & Safety information according to ISO 14001, ISO 9001, OHSAS 18001 and other requirements.
• Represent Sandia on Energy Facility Contractors Integrated Safety Management &
• Quality Assurance Working Group a partnership of national laboratories and government regulators. Collaborate to promote excellence in all aspects of operation and management of DOE through teh ongoing exchange of information and corresponding improvement initiatives.
• Assist Sandia managers and subject matter experts during teh course of ongoing work activities, operational events to ensure all integrated assessments, improvement actions and corrective actions are completed and reported to management and DOE in a timely manner.

Confidential

Business Analyst

Responsibilities:

• Provided tactical direction and legal assistance on large multi-district litigation and approximately 100 class action litigation matters regarding medical device product liability. Partnered wif outside counsel and effected business division. Conducted research, completed discovery requests.
• Analyzed processes, made recommendations and implemented new procedures regarding record retention and database management. Converted paper legal files to electronic data storage and coordinate wif IS Legal Discovery team on best practices for storage of electronic documentation.
• Assisted wif production of both paper and electronic documents for U.S. Securities and Exchange Commission (SEC) investigation. Utilized third party vendors to house e- discovery documents. Provided documentation requested by regulators including Attorneys General, SEC, and teh U.S. Food and Drug Administration (FDA).
• Reviewed medical documents and claims made on recalled medical devices. Teh devices were recalled due to faulty values on nine models. Examined electrical lead damage evidence after teh removal from patients. Followed HIPPA requirements. Reviewed laboratory notebooks and interviewed scientists and laboratory staff regarding projects and technical work gaps.

Confidential

Regulatory Reporting Analyst

Responsibilities:

• Coordinated and designed new process for preparation of teh company's quarterly earnings release and quarterly and annual SEC financial statements, annual report and related year-end filings.
• Created formal processes to ensure that appropriate evidential support was maintained for company's SEC filings and documented as appropriate.
• Drafted technical reports outlining operational, security, financial and safety risks. Participated in large scale effort to transfer external reporting operations from Phoenix, Arizona to Minneapolis, Minnesota. Extensive travel and partnership required to ensure smooth transition.
• Litigation Department, General Counsel's Office Legal Analyst
• Managed teh entire suite of general liability matters for Confidential Company. Hired counsel, and negotiated settlements.
• Led all teh general liability investigations for Confidential Company's locations worldwide.
• Documented incident location, time, and description of events, reviewed police reports and provided recommendation to management regarding outcome of accident, injury, liability and corrective actions.
• Reviewed medical records, documented injuries and medical treatment plans for over 100 cases. Created safety mitigation plans.
• Led team effort in response to regulator requests and managed temporary when required.
• Managed litigation tracking system, implemented new procedures.
• Provided support to clients on litigation process and procedures. Drafted correspondence, reviewed pleadings, and responded to document production requests. Led litigation team special projects; coordinated wif business units and compliance department to ensure litigation representation on senior leadership initiatives.

Confidential

Executive Assistant

Responsibilities:

• Maintained continuing operations plan for worldwide operations.
• Reported local incidents and assisted wif worldwide security incidents.
• Performed technical research and completed special projects.
• Assisted General Counsel wif International Patents and Trademarks provided other legal assistance.
• Maintained compliance wif laws and regulations in over 20 countries.
• Communicated requirements to laboratories in China/Japan.
• Directed critical matters in teh absence of President, CEO.
• Partnered wif information systems to build and maintain supplier/customer database. Tested new products reengineered by R&D team.