Regulatory Affairs Director

Regulatory Strategy Expert For Class III Medical DevicesDevelops and implements global regulatory strategies for Class III medical devices. This individual will be the regulatory subject matter expert for all applicable medical devices. S/he will need to identify, assess and communicate regulatory development and submission strategies, regulatory risks, interface with relevant regulatory authorities and create all regulatory submissions.S/he will develop strategies for regulatory approval, for both US and OUS clinical and pre-clinical trials and will provide regulatory guidance to Clinical Affairs, Quality Systems, Manufacturing and Development. S/he will be responsible for preparing submissions, obtain and maintain their approval while ensuring all activities are carried out in compliance with all applicable laws and regulations.The ideal candidate should be experienced in exercising independent judgment in determining appropriate regulatory actions and requirements for early feasibility and first-in-human studies. S/he will have a strong technical and analytical background with a thorough knowledge of medical device regulations. S/he will be "hands-on", able to function in a start-up like environment, and successful in partnering with senior teams on strategy and execution.Main Responsibilities:Develop and implement regulatory strategies and plans for early feasibility and first-in-human studiesPrepare and submit regulatory submissions to US and international regulatory agenciesCoordinate and communicate with internal and external stakeholders, such as project teams, quality assurance, clinical research, manufacturing, marketing, research and development, and legalReview and approve product labeling, advertising, and promotion for compliance with regulatory requirementsMonitor and analyze changes in regulatory environment and assess the impact on current and future productsMaintain and update regulatory databases, files, and documentationEducation/Experience:Bachelor's degree and 10+ years of experience in the medical device industry, Class III requiredProven track record of regulatory approvals including clinical trials, early feasibility or first-in-human studies preferredMust be able to manage multiple and competing priorities and manage programs with minimal oversight.Experienced leading design assurance activities for new product development.Strong written and verbal communication skillsCritical Thinker, highly organized, efficient and self-motivatedExcellent interpersonal, communication, and negotiating skills.Experience with SaMD and Digital Health appsDemonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills9/80 Schedule