Complaint Handling Manager (#13-5857) AccessClosure
THIS JOB HAS EXPIRED SUMMARY/RESPONSIBILITIES:
SUMMARY: Manage the Company's incident reporting (Complaint Handling) system. Maintain and monitor complaint handling systems, procedures and policies, to ensure that all product complaint investigations received are appropriately investigated and concluded per the company's complaint handling procedure and applicable regulations. Follow up with internal and external sources as necessary to ensure complete documentation of complaint related information.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned on an individual basis:
Define standards, methodology, and workflows for the complaint management system. Responsible for special projects related to the complaint handling process.Review the documentation and investigation of all complaints concerning medical devices.
Notify management of situations that may require regulatory reporting and/or potential product recall.
Responsible for the hiring, development, and ongoing performance management of complaint handling staff
Communicate event investigation results via regulatory reports and written communications, as appropriate.
Review Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities
Develop and report on relevant complaint handling system metrics. Create trend reports, monitor, analyze, document, and report on potential areas of concern for business
Present at senior management meeting, providing summaries/updates of recent complaints
Respond to FDA requests for trending and analysis
Provide training to internal colleagues and external partners regarding complaint handling.
Perform final review/closeout of complaints as necessary.
Bachelor of Science degree or equivalent and a minimum of 8 years of related experience in the medical device or biotech industry, including at least 2 years of previous supervisory experience
Healthcare background, preferably in cardiology
Excellent understanding of GCPs and CFRs
Ability to recognize and analyze data trends
Clear and effective communication skills
Excellent interpersonal and organizational skills
Proficiency in MS Word, PowerPoint, and Excel required
Strong problem analysis and resolution skills, must be thorough and detail oriented
Excellent proofreading, editing, and technical writing skills
Ability to work within strict deadlines, and work on multiple projects accurately and efficiently.
High attention to detail and accuracy is required
Ability to perform multiple tasks concurrently with accuracy
Experience with databases, data analysis, statistics
Work includes potential exposure to human bloodborne pathogens or other potentially infectious materials.
Manage and supervise the complaint handling work-team, set development plans, conduct performance appraisals and fulfil other supervisory/management-related responsibilities for the department and organization as required.
||Santa Clara, CA |
THIS JOB HAS EXPIRED