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Regulatory Affairs

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Support, Design

Projektbeschreibung

A leading global developer, manufacturer and distributor of high-quality medical devices and services that provide solutions for musculoskeletal health, vascular health and pain management. We are currently seeking a Regulatory Affairs Associate I at our global headquarters in San Diego.
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

  • Einsatzort:

    San Diego, California, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland