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Product Surveillance Specialist Job
Date: Nov 5, 2009
Location: Aliso Viejo, CA, 92653, USA
Job Title:
Product Surveillance Specialist
Req #:
5363BR
Job Description:
Position Summary This primary focus of this position is to process product complaints from receipt to closure. Additional responsibilities relate to training other team members, reportability assessment, filing regulatory reports, and communication with supporting departments and upper management. Specific Job Duties The individual must be able to perform the following duties under general supervision: .Receive, evaluate, and document information for all domestic and international complaint files. .Ability to make adverse event reporting determinations to meet domestic and international regulatory requirements (FDA, MEDDEV, CMDCAS, ISO, etc.) .Ability to elevate and engage department management for critical and/or unusual events .Must be able to compose and file regulatory reports to appropriate regulatory agencies. .Ability to interact with Quality Assurance, Engineering, R & D, Customer Service, Clinical Outcomes, Legal, and others as required in order to execute complaint management duties (DHR review, product investigations, root cause analysis, CAPA, special projects, etc.) .Ability to interact with medical professionals and/or consumers via phone or letter to clarify or obtain additional technical information to investigate complaints .Ability to interpret, follow and make required revisions to standard operation procedures as required .Ability to compile and review supporting documents in order to process complaint files from initiation to file closure .Duties include ability to perform data entry, create file folders, labels, letters, filing, fax, scan, and other associated duties as required. .Assist with special projects as required .Responsibilities may require ~ 10% of travel
Qualifications
.Bachelor's degree required with 3-5 years related work experience. .Knowledge of ophthalmic medical terms, Medical Device Reporting regulations, Vigilance reporting regulations, GMPs & ISO requirements for medical devices preferred. .Position requires strong written, oral, and listening communication skills in order to interact with customers and other professionals. Candidate must be able to generate and organize clear, concise responses at different levels of management as required. .Candidate must be proficient in the use of personal computer, including complaint database management, trending and word processing.
Work Location CA - Aliso Viejo Relocation Available No
Status Full-Time
Product Surveillance Specialist
Req #:
5363BR
Job Description:
Position Summary This primary focus of this position is to process product complaints from receipt to closure. Additional responsibilities relate to training other team members, reportability assessment, filing regulatory reports, and communication with supporting departments and upper management. Specific Job Duties The individual must be able to perform the following duties under general supervision: .Receive, evaluate, and document information for all domestic and international complaint files. .Ability to make adverse event reporting determinations to meet domestic and international regulatory requirements (FDA, MEDDEV, CMDCAS, ISO, etc.) .Ability to elevate and engage department management for critical and/or unusual events .Must be able to compose and file regulatory reports to appropriate regulatory agencies. .Ability to interact with Quality Assurance, Engineering, R & D, Customer Service, Clinical Outcomes, Legal, and others as required in order to execute complaint management duties (DHR review, product investigations, root cause analysis, CAPA, special projects, etc.) .Ability to interact with medical professionals and/or consumers via phone or letter to clarify or obtain additional technical information to investigate complaints .Ability to interpret, follow and make required revisions to standard operation procedures as required .Ability to compile and review supporting documents in order to process complaint files from initiation to file closure .Duties include ability to perform data entry, create file folders, labels, letters, filing, fax, scan, and other associated duties as required. .Assist with special projects as required .Responsibilities may require ~ 10% of travel
Qualifications
.Bachelor's degree required with 3-5 years related work experience. .Knowledge of ophthalmic medical terms, Medical Device Reporting regulations, Vigilance reporting regulations, GMPs & ISO requirements for medical devices preferred. .Position requires strong written, oral, and listening communication skills in order to interact with customers and other professionals. Candidate must be able to generate and organize clear, concise responses at different levels of management as required. .Candidate must be proficient in the use of personal computer, including complaint database management, trending and word processing.
Work Location CA - Aliso Viejo Relocation Available No
Status Full-Time
Nearest Major Market: Orange County
Nearest Secondary Market: Los Angeles
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