#ARGEN SOLUTIONS REGISTRATION#
#ARGEN SOLUTIONS ISO#

Working knowledge of FDA, ISO, EU and other applicable regional regulations for handling complaints, reporting incidents, and implementing corrective and preventative actions.

Experience in multiple types of international regulatory submissions (China, Korea, Saudi Arabia, Brazil, Australia, Columbia, Singapore, India, Taiwan, Malaysia, and Vietnam).

Experience with inspection, testing, and troubleshooting.

Bachelor's degree and two years of technical experience or Associate's degree and five years of technical experience.

Degree in Engineering, Quality or a related field.

Supports Research and Development department testing.

Maintains proficiency in broad, regional regulatory requirements.

Serves as a subject matter expert on various regulations and coordinates regulatory issue resolution by using internal resources, regulatory agencies, and outside consultants as need.

Provides guidance to assure all regulatory submissions are planned, communicated and executed per regulatory and business requirements.

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.

#ARGEN SOLUTIONS REGISTRATION#

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.

#ARGEN SOLUTIONS ISO#

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. 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.

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