Open To Work
Lizeth Avalos
La Habra,CA
Summary
Dynamic Regulatory Affairs Manager known for strong analytical skills and effective collaboration. Experience includes leading cross-functional teams to implement labeling strategies and ensure regulatory compliance. Ready to leverage expertise to enhance product safety and efficacy.
Overview
18
18
years of professional experience
Work History
Regulatory Affairs Manager
KARL STORZ Endoscopy - America
El Segundo, CA
07.2008 - Current
- Provide strategic input to FDA Submission teams for 510K submission strategy
- Manage all labeling projects to ensure timelines are met for 510K Submissions, Product Launches, and any other company priority
- Create and design labeling strategies globally
- Ensure FDA and Health Canada Labeling Compliance for North American sites
- Manage Device Labeling for Pre-Market, Post-Market, Remediation, and Device Recalls
- Collaborated with cross-functional teams to ensure regulatory compliance across product lifecycle stages.
- Lead Logistics and other cross-functional teams in executing labeling implementation strategies to ensure adherence to FDA regulatory requirements and compliance standards
- Review Technical Documentation to ensure compliance
- Evaluate labeling and promotional materials for compliance with regulations and guidelines
- Approve Promotional Materials (brochures, videos, announcements) for U.S. distribution
- Provided regulatory guidance to manufacturers and multi-site distributors
- Implement corrective measures intended to prevent post-market field activities
- Prepared responses to inquiries from regulators regarding product safety and efficacy
- Addressed non-conformances and change controls, providing regulatory updates to enhance QA metrics.
- Evaluate changes to documents submitted to determine need for amendments
- Collaborate with global and local stakeholders to improve risk management documentation
- Review cleaning and sterilization protocols as part of Section 17 within a 510K submissionCollaborate with Reprocessing and Sterilization Departments in creation
- of instructions for use based on device cleaning and sterilization validations
- Observed and monitored contracts with outside suppliers to deliver regulatory support
- Provided strategic regulatory input to internal and external stakeholders, ensuring alignment with FDA compliance.
- Reviewed promotional materials for accuracy prior to submission for approval by relevant regulatory bodies
- Reviewed promotional materials for accuracy prior to submission for approval by relevant regulatory bodies
Education
Bachelor of Arts - Clinical Psychology
Brandman University
Orange, CA10-2020
Skills
- FDA submission strategy
- Regulatory compliance
- Labeling compliance
- Regulatory guidance
- Technical documentation review
- Risk management improvement
- People Leader with strong EQ
Languages
Spanish
Professional
Affiliations
Collect clothing for refugees at border towns
Work Preference
Job Search Status
Open to workWork Type
Full TimeLocation Preference
RemoteSalary Range
$175000/yr - $200000/yrTimeline
Regulatory Affairs Manager
KARL STORZ Endoscopy - America
07.2008 - Current
Bachelor of Arts - Clinical Psychology
Brandman University