Senior Manager Regulatory Compliance

Overview

Required skills & experience: • Bachelor’s degree required; advanced degree or Law Degree preferred. • Experience with medical device regulatory submissions (EUA, 510(k) or PMA). • You have at least 7 to 10 years of experience in medical device and/or biopharmaceutical and/or agency/medical education company experience. • Comprehensive knowledge of regulations and guidance governing medical device development and maintenance. • Proven ability to lead and influence others and to collaborate effectively with peers, teams, and with senior leadership. • Clear and effective verbal and written communication skills, and persuasive project management and presentation skills. • Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships. • Experience working on cross-functional teams and within a review committee. • Ability to implement and manage multiple projects simultaneously, with high attention to detail. • Prior experience in a fast-paced startup environment a plus What you need to know: • This is a leadership position within Compliance and will represent the department on product teams and requires a comprehensive understanding of strategic labeling. • You will have significant interactions with Marketing, Medical, Technology and Product teams, leading to product launch. • Participate in the product development team for early development product to provide labeling leadership in developing target labeling concept to guide the design and analysis plan for clinical studies. • Manage regulatory submissions to FDA; draft responses to Agency queries and revised labeling and other requirements for submissions; track FDA requests and responses. • Prepare the submission documents including coordination of all exhibit materials. • Maintain and tracks documents in the document repository as appropriate. • Serve as an internal expert on regulations (FDA and state level regulations), guidance, and enforcement trends governing the promotion of medical devices, and provide guidance to others. • Ensure compliance with applicable laws, regulations and FDA guidelines. • Coordinate with the laboratory Quality Assurance Supervisor to ensure regulatory requirements are being met.

Benefits

Company

We believe that health tests shouldn’t be hard to get – or hard to understand. Our experience is simple. You order one of our kits online, you collect your sample from home and return it via pre-paid mail to one of our fully-certified partner laboratories. A board-certified physician in your state will review and validate your results before you get them. We provide a complete, easy-to-read results report online in just a few days. Our comprehensive tests measure key biomarkers through samples that are collected in the comfort of your home. We empower individuals by providing easy access to health data. We are proud to offer 30+ consumer-initiated, regulatory-compliant tests…without a lab visit.