USA – Regulatory Affairs Associate III in Skaneateles, NY

USA - Regulatory Affairs Associate III - Staffing the Universe - Skaneateles, NY - work from home job Company: Staffing the Universe Job description: Job Description Can be fully remote (USA) or hybrid Under general supervision responsible for the coordination and the preparation of documents/packages for patient monitoring medical device regulatory submissions. Review and evaluate technical and scientific data and reports required for submission in support of company's products. EU MDR support and submissions for Class IIa & Class IIb devices. The incumbent will perform other duties assigned. Track of status and progress of regulatory documentation Review, edit and proofread regulatory documentation Assist in preparation and review of labeling, SOPs, and other departmental documents Compile under supervision regulatory documents for submission Participate as an active team member of project teams as required, Compile and prepare responses to regulatory authorities questions Maintain regulatory files in a format consistent with requirements Maintain awareness of regulatory requirements May be responsible for a specific product portfolio in the region. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Scientific knowledge Written and verbal communication skills Knowledge of regulations Technical systems skills (e.g. word processing, spreadsheets, databases, online research) Proofreading and editing skills Ability to contribute to multiple projects from a regulatory affairs perspective Ability to multitask and prioritize Include the education and experience that is necessary to perform the job satisfactorily. Bachelor's degree or country equivalent in chemistry, biological sciences, regulatory affairs, or related scientific discipline with 3- 5 years regulatory experience, preferably within a medical device and technology environment. Expected salary: $55 - 63 per hour Location: Skaneateles, NY Job date: Sun, 03 Sep 2023 02:31:37 GMT Apply for the job now! Apply tot his job