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Regulatory Affairs
Eingestellt von Real Staffing Group aus Frankfurt am Main
Gesuchte Skills: Support, Design
Projektbeschreibung
Summary: Responsible for supporting a Regulatory Affairs program. Tasks may include record maintenance, product registrations and submissions, field support and assistance on RA projects. This position is considered a trainee position. Work is supervised and reviewed closely.
Essential Duties and Responsibilities:
* Assist other team members with requests involving international registrations.
* Must demonstrate ability to interact with agencies in other countries and ability to communicate effectively
* Must be well-organized and able to track several registrations concurrently
* Good communication skills (phone skills) and strong computer skills are necessary
* Must have the ability to follow through with requests and be resourceful in getting answers
* Perform establishment registration and device listing
* Obtain export certificates as needed.
* Additionally, support all RA teams as needed. Provide input for RA functions involving compliance issues, change orders and design history files.
* Other duties may be assigned.
Requirements : Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education/Experience:
* Bachelors Degree in a science discipline; or equivalent combination of education and experience. Master's degree preferred.
* 1+ year of QA or RA Experience working in an FDA regulated or legal industry.
* Thorough knowledge of FDA regulations, guidance, and policy regarding medical devices.
* RAC preferred.
To find out more about Real Staffing please visit www.realstaffing.com
Projektdetails
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Einsatzort:
San Diego, California, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Sonstiges