Senior Medical Writer

This position requires professional mastery of a specialized field of regulatory expertise that typically requires a bachelor s degree in engineering, Science, or equivalent focus or equivalent certification. Professional knowledge gained through substantial applicable work experience, to supplement formal knowledge, to apply principles and concepts of own subject/technical discipline in resolving issues as they arrive. Requires a minimum of 5 or more years regulatory or equivalent experience within a pharmaceutical and/or medical device company, or similar organization. RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred. Demonstrate knowledge and skills in areas such as regulatory pathways, risk-benefit analysis, communication and collaboration internally and externally, submission, registration, obtaining approval, documentation, compliance, post-marketing surveillance/vigilance and distribution, product development process, design control. Knowledge of application of the regulatory and legal frameworks, regulatory requirements, legislation, processes, and procedures. Knowledge of applicable international regulations and standards (CFR, EU MDR, QSR, ISO 13485, etc.) preferred. Judgement in applying professional expertise and is expected to work independently with minimal supervision. Requires attention to detail in making evaluative judgements based on the analysis of information. Advanced PC skills with proficiency in Microsoft Office Suite, including Excel.