Compiles regulatory filings for EU MDR and rolls them out to the company.Interprets regulatory rules or rule changes and ensures they are communicated through organizational policies and procedures.Conducts internal audits/surveillance to ensure adherence to company procedures/policy in the areas of quality, safety and training.Reviews, interprets and communicates FDA/international regulations and guidance documents to ensure complete scientifically sound product submissions.Identifies risks within regulatory strategies and clearly communicates risks to project teams and regulatory affairs management.Prepares product registration files in international markets with local representatives and obtains local approvals and shipping authorization.Participates in and approves product risk assessments.Supports the implementation of the European Medical Device Regulation.Supports regulatory compliance to ISO 13485:2016, 21CFR820, MHLW, ANVISA, 93/42/EEC, CMDR, MDR, TG(MD)R Sch3.Interacts with regulatory agencies with facilities inspections, licensures and permits.In this role, the successful candidate will: Argen's products are FDA regulated and ISO certified. Argen continues to invest in innovative product improvement initiatives through its Quality Management System to provide our global customers with affordable, high-performance products and industry-leading excellent service. Founded as a precious metals company in South Africa, Argen has evolved into a dynamic, technology-based manufacturing organization focused on three key business segments, including dental alloys, zirconia, and digital dentistry solutions. Do you thrive in a fast- paced and dynamic environment? If you would like to be a part of an organization with an unwavering commitment to quality dental solutions, then explore our career opportunities and get to know Argen.Īrgen is a family-owned and privately held company based in San Diego, CA with a state-of-the-art manufacturing center that provides high quality dental solutions to dental labs of all sizes. foot facility, it is clear that Argen is dedicated to the future of digital dentistry and has positioned themselves for continued advancement and success.Argen is the world’s largest manufacturer of dental alloys and a leader of innovation within the industry, dedicated to improving people’s lives by preserving their greatest physical asset-teeth.Īrgen Corporation currently has an exciting opportunity for a Regulatory Affairs Specialist to join a growing, technology-focused and service-oriented team. This rapid growth has fueled expansion and the purchase of a new 80,000 sq. Argen offers Selective Laser Melted (SLM) copings in high noble, noble and non-precious, Digital Precious Metals in 20 of Argen’s Most Popular Alloys, Argen®Mill milled gold crowns, SLM Captek, ArgenIS Custom Abutments, ArgenZ Zirconia discs and milled units, Digital Models, ArgenPMMA Temps, ArgenWAX and Digital Scanners. Argen’s innovative digital services provide the most complete digital solutions to dental laboratories of all sizes. Today, Argen Digital has grown to over 100 printing and milling machines running 24 hours per day, 6 days per week serviced by over 150 people. Today, Argen’s 40,000 square foot facility houses alloy production, Argen Refining, Zirconia Manufacturing and Argen Digital. By 2010, Anton had positioned the company to start fully integrating into digital and by 2011 Argen officially opened the digital outsourcing center – Argen Digital.
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