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Regulatory Affairs Specialist - Covina, CA - Class II
Eingestellt von Real Staffing Group aus Frankfurt am Main
Gesuchte Skills: Support, Design
Projektbeschreibung
* Proactively partner with R&D, Marketing and other groups to compile appropriate technical documents for regulatory submissions in support of the development project.
* Accountable to develop and maintain the Technical File for the project - with limited guidance and direction.
* Provide training and guidance to product development teams regarding specific product submission requirements.
* Write submission documents for FDA and Health Canada, compile information and write responses to questions from reviewing agencies.
* Identify appropriate standards for application in support of product development; present and guide decisions accordingly.
* Review new regulatory guidance and implement programs to ensure compliance or provide recommendation to Compliance & Training on improvements and opportunities.
* Provide input regarding product recalls or advisory notices, CAPA investigations, and risk assessments.
* May communicate with customers to respond to regulatory concerns/questions.
* Track regulatory department metrics.
* Implement process improvements and updates to regulatory department SOP's.
* Assess regulatory impact on post-market changes on labeling, design, materials, manufacturing process, sterilization or packaging.
Education and Experience Requirements:
* Minimum of a B.S. degree in a technical discipline
* 2-4 years experience in regulatory affairs within the medical device industry or life sciences
* Prior writing premarket submissions experience required
* Must have experience in FDA submissions
* CE technical file requirements experience beneficial
* Demonstrated understanding of FDA's premarket notification requirements and Canadian medical device licensing procedures
To find out more about Real please visit www.realstaffing.com
Projektdetails
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Einsatzort:
Covina, California, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Sonstiges