US Quality and Regulatory Lead

Mativ is a global leader in specialty materials headquartered in Alpharetta, Georgia. The Company offers a wide range of critical components and engineered solutions that connect, protect, and purify our world.

*This role can be based at any of our Health Care facilities based in Dallas, TX, Orangeburg, NY or Knoxville, TN.

Summary of Responsibilities:

The Quality Assurance and Regulatory Affairs Manager - US is responsible for overseeing manufacturing quality teams and processes, ensuring compliance with regulatory standards and customer requirements within the US Health Care organization.

Primary 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.

Qualifications:

• 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 liase 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

WHAT WE OFFER

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.

ABOUT MATIV

Mativ Holdings, Inc. is a global leader in specialty materials headquartered in Alpharetta, Georgia. The company connects, protects, and purifies the world every day through a wide range of critical components and engineered solutions that solve our customers' most complex challenges. We manufacture on three continents and generate sales in nearly 100 countries through our family of business-to-business and consumer product brands. The company's two segments, Filtration & Advanced Materials and Sustainable & Adhesive Solutions, target premium applications across diversified and growing end-markets, from filtration to healthcare to sustainable packaging and more. Our broad portfolio of technologies combines polymers, fibers, and resins to optimize the performance of our customers' products across multiple stages of the value chain. Our leading positions are a testament to our best-in-class global manufacturing, supply chain, and materials science capabilities. We drive innovation and enhance performance, finding potential in the impossible.