Victoria Stockler
Fullerton,CA
Summary
Regulatory Affairs Specialist with extensive experience in the healthcare and medical device industries. Proven ability to ensure regulatory compliance, streamline documentation processes, and coordinate successful product submissions. Adept at collaborating with cross-functional teams and regulatory agencies to meet business objectives while maintaining compliance with U.S. and international regulations.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Specialist
Acumed
04.2022 - Current
- Submitted regulatory filings for new product approvals and renewals, ensuring full compliance.
- Led regulatory strategy and submission timelines across multiple product lines.
- Reviewed and approved corporate procedures, validation protocols, and reports to maintain compliance.
- Collaborated with regulatory agencies in the U.S and internationally to streamline approval processes
Regulatory Affairs Coordinator / Specialist
Endologix
04.2021 - 04.2022
- Managed regulatory documentation and ensured readiness for audits and inspections.
- Coordinated with regulatory authorities, addressing compliance concerns during inspections.
- Collaborated with internal departments to align regulatory objectives with business goals.
- Monitored and interpreted changes in global regulatory requirements, implementing necessary adjustments.
Office Manager / Client Success Manager
Health Pro Wellness Center
05.2017 - 04.2021
- Led hiring, training, and performance management of staff, improving operational efficiency.
- Developed and executed tailored client success strategies, increasing retention rates.
- Oversaw financial records, reconciled accounts, and maintained compliance with industry regulations.
- Streamlined office operations, improving organization and workflow effectiveness.
Skills
- Regulatory Compliance (FDA, Canada)
- Regulatory Submissions & Filings (FDA, Canada, Brazil, Peru, Thailand)
- Risk Assessment & Mitigation
- Document Control & Quality Assurance
- CRM
- SAP
- Salesforce
- Training & Development
- Cross-functional Team Collaboration
- Process Improvement
Certification
Regulatory Affairs Certification (RAC)
Regulatory Affairs Professionals Society (RAPS)
Timeline
Regulatory Affairs Specialist
Acumed
04.2022 - Current
Regulatory Affairs Coordinator / Specialist
Endologix
04.2021 - 04.2022
Office Manager / Client Success Manager
Health Pro Wellness Center
05.2017 - 04.2021
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