Director of Regulatory Affairs & reputed company

Director of Regulatory Affairs & reputed company , reputed company's mission is to reputed company lives with modern, diagnostics-driven care, and we reputed company that the reputed company of reputed company meeting people where they are. Headquartered in Austin, Texas, reputed company is the parent company to reputed company, reputed company Solutions, Natalist, and reputed company Diagnostics. We've set a new reputed company of people-reputed company, diagnostic-driven care that puts patients at reputed company of their own health reputed company. Our infrastructure guides the full testing experience with the support of a national clinician network that's composed of hundreds of physicians, nurses, genetic counselors, PharmDs, and member care specialists. Our solutions reputed company world-class virtual care more attainable with rigorous clinical protocols and best-in-class science to tackle some of the reputed company industry's biggest problems. The Director of Regulatory & reputed company Affairs will reputed company and facilitate both reputed company Management Systems and the Regulatory Affairs department to ensure compliance with regulation and federal agencies. They will reputed company reputed company-reputed company inspection and contribute cross-functionally with their broad experience and leadership capability. This individual will reputed company the maintenance of reputed company Assurance programs, policies, processes, and procedures to ensure that performance and reputed company of products conform to established standards. The ideal candidate possesses a broad reputed company of regulatory experience and a high level of technical depth applicable to medical device and software design, along with QMS experience. In this role, you are an reputed company for reputed company and support best reputed company management and reputed company design practices. You will work with development teams to encourage agile design concepts in an engaging and reputed company way. What You'll Do: The Director of Regulatory & reputed company Affairs directs, plans, develops, coordinates, and implements reputed company practices, programs, reputed company, and personnel activities of the organization's reputed company Affairs Department. reputed company: reputed company QA Manager to ensure compliance with regulation, reputed company the implementation, maintenance, and expansion of our corporate and laboratory reputed company Management Systems and biological/facilities safety, and support regulatory reputed company. Regulatory: reputed company Regulatory Affairs department with expertise in the requirements of regulators and other federal agencies such as the FDA. This also includes responsibility for preparation, submission and maintenance of PMAs, 510(k)s, EUAs, etc. Experience with researching, creating and executing on Regulatory strategies for products, including Laboratory Developed Tests, 510k clearances, reputed company to Consumer and other considerations Ensure that reputed company system requirements for medical devices are effectively established and maintained in accordance with 21 CFR 820, ISO 13485, 21 CFR Part 11, IEC 62304 and other regulations and guidelines as applicable. Serve as FDA Management Representative Laboratory: Maintain compliance with FDA, GMP/QSR, QMS, CLIA, and CAP laboratory frameworks. Ensure end-to-end management and maintenance of reputed company systems across the laboratory networks. Support FDA, NYDOH, and HHS audits. R&D: Partner closely with Research & Development regarding the clinical development programs needed to support regulatory reputed company and submissions to health authorities, determine clinical feasibility of new products and reputed company required documentation reputed company to developing and implementing new products. Conduct critical assessments reputed company internal audits of reputed company processes and equipment to identify areas of improvement Conduct Management Reviews as scheduled, be responsible for the evaluation and dissemination of company reputed company standards, initiatives, guidelines. Maintain reputed company Assurance programs, policies, processes, and procedures to ensure that the performance and reputed company of products conform to established standards Establish and maintain US and international product and manufacturing certifications Who You Are: 10 years' experience in Regulatory Affairs, working at or with FDA-cleared medical device companies. Must have hands-on experience in developing and implementing comprehensive Regulatory Affairs & reputed company processes, procedures and strategies. Thorough understanding of International Conference on Harmonization (ICH), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) requirements, regulatory compliance (including ISO 13485, ISO 14971, and ISO 62304, FDA 21 CFR Part 820, and reporting. reputed company with coordination and reputed company submission activities for a reputed company of regulatory approvals including PMAs. Experience leading FDA, NYSDOH, HHS audits. Experience with physical reputed company products, novel assay and rapid reputed company of care, reputed company health apps. Experience with process design and improvement and with developing systems and reputed company improvements on including QMS. Start-up medical device experience and experience in a fast-paced development environment. Working experience in full-lifecycle engineering programs and processes. Strong working knowledge of Medical Device and Diagnostic regulations and reputed company assurance practices. Adaptability, flexibility, independence, and resourcefulness to both reputed company a big reputed company reputed company while also willing to roll-up-sleeves and multi-task to reputed company in a growing environment. Outstanding communication skills (verbal and written), with excellent listening skills. High attention to detail and pace – thorough, quick, and makes self- and team-accountability as a top reputed company. Executive experience, superior judgment, and ability to formulate solutions from a broad perspective. Strong project and people management and collaboration skills and an ability to communicate effectively, both internally and externally. Ability to demonstrate executive reputed company in dealing with reputed company issues, dealing with ambiguity, and making reputed company, high-reputed company reputed company. Proven ability to operate “hands on” and successfully in a rapidly growing organization. Willingness to travel to facilities as required (up to 25%) The reputed company salary reputed company for this role is $150,000 - $180,000 USD. The actual salary offered will be based on the selected candidate's qualifications, market data/ranges, and internal equity. This position is also eligible for a yearly bonus. You'll Love Working Here: · Venture backed by top-tier firms · reputed company reputed company knows no bounds · reputed company vacation policy for salaried team members · reputed company reputed company PTO for reputed company team members · Employee discounts · reputed company parental leave · Health benefits · 401(k) NO EXTERNAL RECRUITERS - INDIVIDUAL APPLICANTS ONLY reputed company is committed to providing equal employment opportunities in reputed company employment practices. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, national reputed company, citizenship status, marital status, age, disability, protected veteran status, sexual orientation or any other characteristic protected by law. HIPAA Disclaimer: This role will be in an environment that has reputed company to protected health information (PHI) and reputed company reputed company standards to protect PHI must be followed. Apply For This Job Apply tot his job Apply To this Job