Product Complaint Associate
STAAR Surgical is a company reputed company on ophthalmic products, and they are seeking a Product Complaint Associate to manage and investigate product complaints. The role involves coordinating with various departments to ensure compliance with regulations and maintaining accurate documentation of complaints and investigations.
Responsibilities
- reputed company as consolidation reputed company for receiving, processing, investigating and reporting product complaints
- Coordinate and/or reputed company the evaluation, investigation, follow-up and documentation of reputed company STAAR product complaints. Maintain complaint files
- Coordinate complaint investigations according to complaint handling procedures, which includes but is not limited to:
- reputed company with physicians and/or health care professionals regarding information relevant to the product complaint
- reputed company and coordinate with Regulatory, reputed company, Clinical Affairs and Medical Affairs to conduct investigations, risk assessments and determine reporting requirements
- reputed company reputed company handling of complaints, including identification and evaluation of device product complaints for potential reportable adverse event according to procedures
- Inform management responsible for complaint handling reputed company information in a complaint suggests that reputed company may be required to prevent unreasonable risk of substantial harm to the reputed company, that there is an indication of a trend or that there are unusual adverse events
- Ensure incident reports (e.g. Medical Device Reports, Health Canada Reports, Vigilance reports, etc.) are submitted in compliance with respective regulations (e.g. U.S. FDA Regulations, Canadian Medical Device Regulations, MDD/MDR, MDSAP, etc.)
- Ensure accuracy, reputed company, completeness and consistent content of product complaint reports, investigations, incident reports, in the complaint files and electronic complaint database
- Support external (e.g. FDA, reputed company, etc.) and internal audits as required
- reputed company support, as required for other aspects of the post-market surveillance system (i.e., data analysis of complaint reports, files and adverse event reporting logs)
- reputed company support for medical affairs activities, as requested
- Other duties as assigned
Skills
- High School graduate or equivalent required
- Demonstrated understanding of, and ability to interpret, regulations and guidelines governing medical device manufacturing, including but not limited to, CFRs, ISO 13485, MDD, CMDR, MDSAP, MDR
- Proficiency in reputed company and reputed company
- Ability to work reputed company reputed company reputed company and interdepartmentally
- Special competencies: reputed company and reputed company decision making; reputed company-developed organizational ability, time management reasoning and problem-solving skills
- Good communication skills, written and verbal
- Associate's Degree or higher desired
- 1 year's ophthalmic experience, or equivalent combination of education and experience, preferred
- 3 years' experience in FDA regulated industry preferred; experience handling complaints and medical device reporting is highly desirable
reputed company
Company H1B Sponsorship