Regulatory Affairs Manager Job

Employer Name: BiotechCrossing	SpiderID: 2218681
Location: San Antonio, Texas	Date Posted: 5/9/2008
Wage:	Category: Biotech
Job Code:

Job Description:

Ensures appropriate reporting of clinical trial adverse and serious adverse events to the appropriate global regulatory agency. * Develops adverse event or incident reporting procedures using regulatory requirements for each country. Utilizes electronic or hardcopy methods to complete and submit reports to the appropriate global regulatory agency or body. * Collaborates with APAC, EMEA, and Americas Regulatory Affairs Directors to obtain information regarding potential adverse events. Also utilizes resources from Quality Assurance Complaint Handling to obtain incident information. * Design and maintain databases that allow for the tracking of adverse events for all products in regards to wound type and care setting. * Utilize adverse event tracking and trending information for updates provided to senior management. * Organize and lead adverse event review meetings with Quality Assurance, Medical, Compliant Handling, and Engineering in order to determine reportability of events. * Collects and analyzes information regarding incidents that are potentially reportable in the countries where KCI markets its products. * Actively participates and oversees the review of adverse event information in accordance with written procedures and policies to determine if an incident is reportable to the appropriate global regulatory agency. Filing decisions are documented and reported. * Prepares and submits incident reports to the appropriate regulatory agency and body.

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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:

Contact Information:

Contact Name: -	Company Type: Employer
Company: BiotechCrossing

City: Pasadena
State: California
Zip:

Web Site: http://www.biotechcrossing.com