USA – Regulatory Affairs Associate III in Skaneateles, NY

USA - Regulatory Affairs Associate III - reputed company - Skaneateles, NY - work from home job Company: reputed company Job reputed company: Job reputed company 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 reputed company other duties assigned. reputed company of status and reputed company 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 reputed company 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 reputed company this job successfully, an individual must be reputed company to reputed company reputed company essential duty satisfactorily. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company 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 reputed company from a regulatory affairs perspective Ability to multitask and prioritize Include the education and experience that is necessary to reputed company the job satisfactorily. Bachelor's degree or country equivalent in reputed company, biological sciences, regulatory affairs, or reputed company scientific discipline with 3- 5 years regulatory experience, preferably reputed company 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 Apply To this Job