Quality Regulatory Manager

Company: National Biological Corporation
Location: Beachwood
Posted on: May 15, 2022

Job Description:

National Biological Corporation is the global leader in FDA-cleared phototherapy devices for the treatment for psoriasis, vitiligo, and other skin conditions. Founded in 1967 and headquartered in Beachwood, OH, our products are employed in major hospitals including the Cleveland Clinic and Mayo Clinic, and within the homes of patients around the world. National Biological Corporation is an affiliate of Madison Industries, one of the largest and most successful privately held companies in the world. Madison builds entrepreneurially driven, branded market leaders that are committed to making the world safer, healthier, and more productive by creating innovative solutions that deliver outstanding customer value. General Summary: Manager of Quality & Regulatory will oversee our Quality Management System and lead continuous improvement efforts in support of our innovative phototherapy devices and technologies. This role will directly develop and lead the quality organization and be accountable for all aspects of quality and regulatory, including quality engineering, quality assurance, quality control, document control, training, and internal & external audits, including FDA and Medicare regulatory compliance. Essential Duties and Responsibilities: Lead the quality organization, developing direct reports, and establishing key performance indicators (KPIs) for each area of responsibility Oversee the Quality Management System, implementing improvements to ensure patient safety while also meeting operational productivity goals Maintain compliance with ISO 13485, FDA, Medicare, and other regulatory bodies, conducting management reviews and leading internal and external quality audits as appropriate Identify and drive continuous improvement activities and ensure cross functional alignment Oversee supplier quality, working closely with procurement to select and quality reliable, quality-driven partners Work closely with Product Development to build quality into products and processes Participate in strategic planning and departmental budget exercises Qualifications: Demonstrate our core values of Bias for Action, Entrepreneurial Mindset, and Building Trust Possess a working knowledge of FDA regulatory and ISO 13485 compliance Have a commitment to good documentation practices Strong data collection and analysis capabilities Excellent interpersonal skills and ability to work with others in a positive and collaborative manner Education and Experience: Bachelor---s degree in a technical discipline: engineering, chemistry, biology, statistics, etc. Experience in FDA regulated medical devices, pharmaceutical, or biotechnology industries 5 years of Quality Assurance experience An equivalent combination of education and experience will be considered National Biological benefits include Health care, Dental, Vision, HSA, FSA, 401k retirement savings with company match, paid time off, and paid holidays.

Keywords: National Biological Corporation, Cleveland , Quality Regulatory Manager, Executive , Beachwood, Ohio