Vakante Jobangebote finden Sie unter Projekte.
Senior Specialist/Manager, Regulatory Affairs
Eingestellt von Real Staffing Group aus Frankfurt am Main
Gesuchte Skills: Engineering, Support
Projektbeschreibung
* Prepares timely amendments, supplements, annual reports and other regulatory documents for review and approval by Manager.
* Interfaces with other departments to provide Regulatory advice and obtain the necessary documents and draft reports and narrative components in accordance with regulatory agencies' guidelines.
* Prepare and submit PMA or 510(k)s (FDA) and/or International submissions experience to obtain regulatory clearances for new products and product changes in a timely manner.
* Prepare "Memo to File" reports to support internal filings for product development projects and product changes.
Requirements/Qualifications:
* 4+ Years Regulatory Affairs Experience
* BA/BS Degree (Engineering or Scientific Field a plus)
* Expertise in Pre-Market notification 510(k) guidelines and/or International Regulatory Affairs
* RAPs (preferred)
To find out more about Real Staffing please visit www.realstaffing.com
Projektdetails
-
Einsatzort:
Los Angeles, California, Vereinigte Staaten
-
Projektbeginn:
asap
-
Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
-
Kategorie:
Ingenieurwesen/Technik, Sonstiges