Purpose of the position: Provide leadership in Regulatory Affairs and Quality Assurance for all products and processes in the company. Ensure regulatory compliance and adherence to quality assurance responsibilities by managing the Quality System and having a thorough understanding of FDA and ISO 13485 regulations.
• Develop long and short-term plans projecting regulatory and quality assurance programs and objectives, including capital and operating budgets.
• Lead and develop RA/QA department, which may include QA Engineers, Technicians, Specialists and Inspectors, to ensure clear communication, meaningful employee development, and motivation.
• Maintain compliance with FDA and ISO requirements. This includes being part of the team for FDA and ISO audits.
• Oversee adherence to an effective corrective and preventive action (CAPA) system.
• Oversee adherence to an effective complaint handling system.
• Act as on the onsite Management Representative.
• Adhere to the cGMP and cGLP guidelines as well as the guidelines established by other regulatory bodies.
• Direct cross-functional efforts to improve the quality system and assure suitability with all products.
• Proactively investigate and initiate opportunities for the continued development of new regulatory/quality programs such as GMP training, Lead Auditor Training, Lean Management, etc.
• Encourage a teamwork approach with Manufacturing, Research and Development, Engineering, Marketing and Sales and facilitate an atmosphere of prompt resolution to complex issues when they arise.
• Monitor progress against budget and inform upper management of deviations with specific correction recommendations.
• Proactively enhance the company’s core technologies by developing regulatory plans, quality plans, FMEA, and or test plans for new products.
• Represent RA/QA on new product and project teams.
• Oversee 510(k) and product submissions and maintain FDA registrations/certificates, product Technical Files, ISO certificates and other product regulatory certificates.
• Organize and schedule Quality Management Reviews as required by the Quality System.
• BA or BS degree in a technical discipline, with a minimum of 5 years’ experience in a regulated industry is required. Masters in Business or Field of study preferred.
• Must have a sound understanding of how to lead a multi discipline team.
• Must have a sound understanding of manufacturing operations.
• Must be knowledgeable and able to operate under cGMP, cGLP and ISO 13485 regulations.
Please forward resumes to: Jennifer Holte at firstname.lastname@example.org