- LSI Solutions (Victor, NY)
- …regulatory submissions and perform duties related to regulatory post-market surveillance, and vigilance reporting ; 5) read and interpret regulations for new and ... Proficient in project planning and tracking. + Knowledge of domestic and international vigilance reporting requirements for medical devices. + Love of Learning… more
- Abbott (Alameda, CA)
- …requirements, internal Quality System procedures and guidelines related to medical device vigilance reporting . + Adapt processes and documentation to align with ... products. Accountable for meeting the compliance requirements for Medical Device Reporting regulations including (803). This includes but is not limited to:… more
- Abbott (Alameda, CA)
- …but not limited to: Complaints Trending and summaries; FDA Medical Device Reporting trending and summaries; EU Medical Device Vigilance reporting ... trending and summaries; and Weekly, monthly and quarterly product line complaints reporting . + Support internal and external audits by preparing and providing… more
- Kelly Services (Redondo Beach, CA)
- …for Regulatory Submissions + Responsible for Adverse Event ( Vigilance , MDR) Reporting and Assessment, Evaluation of Product Complaints , and AE Report ... **Title** : Regulatory Affairs Specialist (Senior Level) **Pay** : $38-$50/hr depending on...to hire** **Overview:** We are seeking a Regulatory Affairs Specialist (Senior Level) to ensure company compliance with US… more