My name is Paige, and I represent The Fountain Group. We are a national staffing firm and are currently seeking a candidate for a Product Safety Expert for a prominent client of ours. This position is located in Duluth, GA. Details for the positions are as follows:
· Perform triage of incoming AE reports for classification, completeness, consistency and seriousness; prioritize and report per regulatory and company guidelines
· Evaluate incoming field reports, product returns and ...
Responsibilities:
• Assist senior Regulatory Affairs professionals in on-time and effective submissions to global Health Care authorities, timely filing of related period reports and maintenance of records.
• Assist, prepare and maintain regulatory documents for registration according to FDA and Departmental requirements.
• Review and maintenance of packaging and labeling materials.
• Communicate with Global Regulatory Associates to provide them external and internal documents they require in ...
Responsibilities:
• Accurate and timely complaint entry.
• Capture of all applicable information into the complaint management system, performing follow-up attempts to obtain necessary information, requesting return of and forwarding any product received with a complaint to the appropriate verification center.
• Apply technical knowledge to provide direction and coordinate additional complaint activities with internal, field, and end use customers.
• Perform triage of incoming complaints for ...
Responsibilities:
• Accurate & timely reporting, effective investigations, proper analysis, timely filing of Adverse Events and compliance with international (e.g. FDA, ISO), regional (e.g. MDD) & country (e.g.France,Japan) regulations.
Skills:
Minimum Required:
• BS/BA or relevant work experience related discipline or equivalent relevant work experience
• 3-5 years of relative experience with 1-2 years experience within contact lens or medical device industry within one of the following functions: ...
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