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Mativ · 3 days ago

US Quality and Regulatory Lead

United States

Full-time

Remote

Senior Level

5+ years exp

Mativ is a global leader in specialty materials headquartered in Alpharetta, Georgia, and they are seeking a Quality Assurance and Regulatory Affairs Manager for their Health Care organization. This role is responsible for overseeing manufacturing quality teams and ensuring compliance with regulatory standards and customer requirements within the US Health Care organization.

Industrial EngineeringManufacturingSupply Chain Management

Responsibilities

Lead a team of site Quality Managers, responsible for implementation and execution of Quality Management System in line with ISO 13485, US and International Medical Device, Pharmaceutical and Cosmetic requirements

Implement and oversee the company's Risk Management processes in line with ISO 14971 requirements

Measure achievement of goals, identify trends and opportunities for improvement, and support the business in achieving its overall strategic goals

Manage the external audit process with Notified Bodies, Regulatory Authorities, and Customers to ensure a positive outcome

Maintain an awareness of new and proposed legislation that impacts the business and communicate/implement as required

Ensure that quality and regulatory requirements are integrated into all aspects of product development, commercialization and change management

Promote a culture of quality and compliance to regulations, standards and procedures and risk management throughout the organization

Qualification

ISO 13485ISO 14971Quality Management SystemMedical Device quality systemsRegulatory AffairsRisk ManagementProcess validationManufacturing PracticesLaboratory PracticesComplaint HandlingCAPASoftware validationMicrosoft applicationsMinitabERP systemsEQMS systemsCommunicationTeam leadership

Required

Bachelor's Degree in life sciences, engineering or similar technical field with a minimum of 5 years' experience in a quality assurance or regulatory affairs within the medical device or pharmaceutical industries

Excellent written and verbal communication skills to effectively liaise with regulatory authorities and internal stakeholders

Expertise and experience with Medical Device and OTC Drug quality systems and techniques, such as Complaint Handling, CAPA, process validation, software validation, sterilization, Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and design controls

Strong skills in various applications including Microsoft, Minitab, and ERP and eQMS systems

Benefits

Mativ benefits say a lot about how we care for each other. Our employees and their families have many different needs. As a result, our benefits offer choices on many levels and are high in quality, competitive in the marketplace, and affordable.