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Regulatory Affairs Specialist III

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Support, Engineering

Projektbeschreibung

Essential Duties and Responsibilities:
Include the following. Other duties may be assigned.
* Draft and obtain approval for Pre-Market Approval (PMA) supplements, Investigation Device Exemptions (IDE), Pre-Market Notification (510(K)) submissions, and international regulatory submissions.
* Maintain approval on all applications through the submission of supplements, amendments, and annual reports, including adverse event reporting and remedial action activities.
* Interact with the scientific reviewers at FDA or international competent authorities through phone calls, or when necessary, face-to-face meetings as directed.
* Research & advise regarding FDA or international compliance actions and assist in writing responses to any regulatory enforcement letters. Conduct face-to-face meeting with respective authorities, as needed.
* Review ans submit MDR/Vigialnce reports to FDA and international regulatory bodies, as required. Compile data and metrics for MDR/Vigilance events.
* Support in communicating to internal departments regularly on the current regulatory environment or issues.
* Review changes to cleared or approved devices to determine if new submissions or letters-to-file are necessary.
* Review and approve company marketing literature and ensure that it is in compliance with product labeling as approved by regulatory authorities such as the FDA.
* Interact with Quality Assurance, Engineering, and Manufacturing to ensure that manufacturing of products are in accordance with all applicable regulations.
* As required, will support regulatory due-diligence review of future acquisitions & will support the transfer of products into the USA & other DJO facilities.
* Provides support in coordinating clinical & non-clinical study agreement review, approval, study database and record maintenance.
* Other duties as assigned.
* Some travel will be required.

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.
* 4-6 years as a regulatory professional in FDA regulated industry, including 2-3 years in the medical device industry.
* Thorough knowledge of FDA regulations, guidance, and policy regarding medical devices.
* RAC preferred
To find out more about Real please visit www.realstaffing.com

Projektdetails

  • Einsatzort:

    Carlsbad, 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