Summary
Overview
Work History
Education
Skills
Websites
Certification
Timeline
Generic

TRACY A. BERO

Orlando,FL

Summary

Seasoned and focused leader with a proven track record in overseeing regulatory and legal compliance initiatives, designing effective quality systems, compliance programs, and litigation management strategies to improve overall regulatory systems. Well-versed in managing all aspects of US compliance, providing input for international compliance, and securing positive results in audits and FDA inspections. Certified Compliance and Ethics Professional with expertise in developing and implementing comprehensive compliance strategies to guarantee adherence to industry regulations and legal standards. Renowned for ensuring compliance with all local, state, and federal laws and creating overall policy and procedure documents in collaboration with US and UK legal counsel. Demonstrated exceptional aptitude in integrating compliance considerations into business operations, instilling a proactive compliance mindset across the organization, and adeptly navigating regulatory challenges. Credible history of spearheading state corporate compliance and licensing requirements, encompassing state qualification and annual reports. Certified Paralegal instrumental in minimizing legal risks, driving sustained regulatory excellence, product compliance, confirming organizational integrity, and coordinating with legal counsel to achieve compliance and legal objectives. Adept at applying sound risk management principles and navigating evolving regulatory frameworks to inform strategic decision-making.

Overview

23
23
years of professional experience
1
1
Certification

Work History

VP of Compliance – Regulatory & Legal Compliance

Acorn Stairlifts, Inc.
01.2011 - 09.2023
  • Planned and implemented compliance programs for a leading global Medical Device company with a multi-million-dollar portfolio in the United States
  • Developed a quality management system (QMS) aligned with 21 CFR 820 and served as the management representative by overseeing FDA compliance and conducting internal company investigations.

Senior Litigation Paralegal

Rotech Healthcare Inc.
03.2002 - 12.2010
  • Performed comprehensive research on legal and regulatory issues to ensure adherence to state and federal laws, including HIPAA
  • Prepared managed care credentialing applications and responded to VA contract request for proposals (RFPs)
  • Offered legal assistance to the chief legal officer, associate general counsel, and compliance officer
  • Developed and deployed management systems for litigated and regulatory affairs.

Legal Assistant

Morlan & Stovash
12.2000 - 10.2001
  • Performed thorough research and drafted pleadings, memoranda, and various legal documents pertaining to mortgage foreclosures, homeowners' associations as well as asbestos and construction litigation
  • Requested and evaluated foreclosure/title reports and property records while confirming comprehensive analysis
  • Ensured compliance with all relevant laws and regulations governing legal practices.

Education

Bachelors of Science (BSc) in Accounting & Finance with Foundation, Upper Credit -

Liverpool Polytechnic/John Moores University
Liverpool, England

Associate of Science (A.S.) in Paralegal Studies, ABA Approved Program -

Southern College
Orlando, FL

Skills

  • Strategic Leadership
  • Compliance Operations Management
  • FDA Reports of Corrections & Removals
  • Contract Negotiation & Management
  • Litigation Management & Legal Operations
  • Business Process Improvement
  • Risk Assessment & Management
  • Compliance Regulations & Auditing
  • Professional & Business Ethics
  • Quality Assurance & Management
  • Problem Identification & Resolution
  • Business Strategy Development
  • Strategic Planning & Execution
  • Project Management
  • FDA-21 CFR 820
  • Corporate Governance
  • Legal Research & Writing
  • ISO 13485 Standards
  • FDA Product Recalls
  • Business & Trend Analysis
  • Microsoft Office Suite
  • Westlaw
  • PACER
  • Case Text
  • Talent LMS
  • Cascade

Certification

  • National Association of Legal Assistants (NALA), Certified Paralegal, NALA - The Paralegal Association, 2000
  • Certified Compliance & Ethics Professional (CCEP), Society of Corporate Compliance and Ethics (SCCE) 2016
  • Florida Notary Public

Timeline

VP of Compliance – Regulatory & Legal Compliance

Acorn Stairlifts, Inc.
01.2011 - 09.2023

Senior Litigation Paralegal

Rotech Healthcare Inc.
03.2002 - 12.2010

Legal Assistant

Morlan & Stovash
12.2000 - 10.2001

Bachelors of Science (BSc) in Accounting & Finance with Foundation, Upper Credit -

Liverpool Polytechnic/John Moores University

Associate of Science (A.S.) in Paralegal Studies, ABA Approved Program -

Southern College
TRACY A. BERO