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Senior Regulatory Affairs Specialist - Chino, CA - Class II
Eingestellt von Real Staffing Group aus Frankfurt am Main
Gesuchte Skills: Engineering, Support
Projektbeschreibung
* Prepare worldwide regulatory submissions for new devices and modified devices as required
* Work efficiently with project development teams and obtain deliverables for US and international submissions to meet regulatory requirements
* Provide RA strategies/plan, guidance and assessments to project team members during new product development, and sustained engineering projects
* Coordinate and prepare responses to FDA Deficiency Letters and other foreign health authorities' requests. Corresponded with FDA to discuss agency comments and follow-up on submissions
* Prepare and managed STED documents, Technical Files/Essential Requirements to gain CE mark and foreign registration submissions
* Review and assess regulatory impacts for the product design/process change on regulatory filings for Class II devices
* Review and approve device labeling and advertising materials and assured compliance with applicable US and international regulatory requirements
* Analyze and recommend appropriate changes and adding of supporting data and ensured the consistency with approved claims
* Collaborate with US & OUS corporate RA partners to support global submissions of new product registration and re-registration of existing products
Qualifications:
* 3+ years of regulatory affairs experience working for a medical device company
* International regulatory experience
* Experience working on 510(K) clearances for the FDA
* Bachelor's degree
* Dental device experience a plus
* Master's degree a plus
To find out more about Real please visit www.realstaffing.com
Projektdetails
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Einsatzort:
Chino, 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:
Ingenieurwesen/Technik, Sonstiges