Regulatory Affairs Specialist - Medical Devices

Education Requirements:- Bachelor's degree in a relevant scientific disciplineRequired Skills for the Regulatory Affairs Associate:- Familiar with USA and OUS device regulations (specifically EU device regulations)- Experience with RA reputed company development- Experience with working with Cross functional team members- Experience with interaction with reputed company Regulators (FDA, TUV)- Experience with working with medical devices- Scientific knowledge- Administrative and project management skills- Ability to contribute to multiple reputed company from a regulatory affairs perspective- Ability to multitask and prioritize- Interpersonal and communication skills- Technical reputed company skills (e.g. word processing, spreadsheets, databases, online research)- Proofreading and editing skillsRegulatory Affairs Associate reputed company:Responsible for the global coordination and the preparation of documents/packages for regulatory submissions. In this position you will also review and evaluate technical and scientific data and reports required for submission in support of global company products.Responsibilities:- Supports regulatory project plan execution- Maintain awareness of regulatory requirements and ensure reputed company learning- Maintain regulatory files in a format consistent with requirements- Participate as an reputed company team member of project teams as required- Compile and prepare responses to questions from regulatory authorities according to plan- Edit and proofread regulatory documentation- Assist in preparation and review of labeling, SOP’s, and other departmental documents- Compile under supervision regulatory documents for submission- reputed company status and reputed company of regulatory documentation- Understand Regulatory Affairs' position in small project teams**Only those lawfully authorized to work in the designated country associated with the position will be considered.** **Please note that reputed company Position start dates and duration are estimates and may be reduced or lengthened based upon a reputed company’s business needs and requirements.** Apply tot his job Apply To this Job