Director of Regulatory Affairs
Who you are: * Oversee and ensure adherence to proper labeling, advertising/promotional material and claim substantiation. * Review laws, regulations and guidance. Determine the potential effects on the company and work with other internal stakeholders to implement the best practices for regulatory compliance. Compile regulatory trends. * Oversee the securing of product approvals or clearances, registrations, listings, and facility licenses. * Interact with regulatory authorities, federal and state government officials and their staffs, plus trade associations and industry coalitions to achieve favorable outcomes. * Bachelor degree required. * At least 7 years of experience in regulatory affairs including both US FDA and International experience in Medical Devices or OTC Drugs. * At least 5 years of experience managing people, including hiring, developing, motivating and directing people as they work. * Knowledge of Regulatory Affairs with diverse experience in regulated industry (Device, Pharma, Personal Care or Food). * Experience diagnosing, isolating, and resolving complex issues and recommending and implementing strategies to resolve problems * Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines. * Exceptional communication skills required. * Strong leadership skills with a proven track record of building high performing teams and talent development. What you'll do: * Ensure institutional knowledge of the requirements for product submissions for regulatory authority clearance or approval by working with vendors, internal customers and consultants as needed. * Train employees in general regulatory requirements needed to perform their jobs. Initiate or maintain relevant procedures or SOP's, updating as needed and training when required. * Develop and mentor staff through on-boarding, open communication, training and development opportunities and performance management processes; build and maintain employee morale and motivation; ensure the team is appropriately staffed with required competencies. What you'll get: * The opportunity to improve patient outcomes. * Influence on the strategies the company utilizes to impact their short-term and long -term goals as well as your own. * Recognition and reward for you contributions in a meritocratic environment. * Quick feedback loops where you can immediately see the direct results of your work. You'll be working on a team that has direct impact on the profitability of the company as a whole. * Excellent total compensation package, including generous performance-based bonuses and fully comprehensive benefits. If it sounds like you could potentially be a good fit for this opportunity, please apply to this job posting and send your resume to m.sheriff at realstaffing.com Sthree US is acting as an Employment Agency in relation to this vacancy. Sthree US is acting as an Employment Agency in relation to this vacancy.