Regulatory Affairs Specialist

About Medical Industry In detailed Job Description: Under general direction, will oversee Regulatory, Quality Assurance & Compliance and develop and implement department goals, objectives, and systems to ensure compliance with Quality System regulations established by internal procedures, the US FDA and applicable international regulatory bodies and/or standards. Essential Duties and Responsibilities include the following. Other duties may be assigned. Required Skills · Knowledge of FDA’s 21 CFR Part 820 (Quality System Regulation), and 21 CFR Part 11 (Electronic Records; Electronic Signatures). ISO 13485 Medical Device Directive, and the Canadian Medical Device Regulations, and the Australian Therapeutics Goods Administration regulations (as applicable) at an advanced level.…