Regulatory Affairs Specialist
- San Diego, CA
Regulatory Affairs Specialist
Argen Corporation currently has an exciting opportunity for a Regulatory Affairs Specialist to join a growing, technology-focused and service-oriented team. 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.
Argen 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. 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. 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. Argen's products are FDA regulated and ISO certified.
In this role, the successful candidate will:
• Provide regulatory guidance in areas including regulatory strategy for product submissions and regulatory compliance activities. Develops and maintains domestic and international submissions. Reviews international and domestic labeling, marketing communications and product design documentation ensuring compliance with regulatory requirements.
• Interacts with regulatory agencies with facilities inspections, licensures and permits.
• Supports regulatory compliance to ISO 13485:2016, 21CFR820, MHLW, ANVISA, 93/42/EEC, CMDR, MDR, TG(MD)R Sch3.
• Supports the implementation of the European Medical Device Regulation.
• Participates in and approves product risk assessments.
• Prepares product registration files in international markets with local representatives and obtains local approvals and shipping authorization.
• Identifies risks within regulatory strategies and clearly communicates risks to project teams and regulatory affairs management.
• Reviews, interprets and communicates FDA/international regulations and guidance documents to ensure complete scientifically sound product submissions.
• Conducts internal audits/surveillance to ensure adherence to company procedures/policy in the areas of quality, safety and training.
• Interprets regulatory rules or rule changes and ensures they are communicated through organizational policies and procedures.
• Compiles regulatory filings for EU MDR and rolls them out to the company.
• Provides guidance to assure all regulatory submissions are planned, communicated and executed per regulatory and business 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.
• Maintains proficiency in broad, regional regulatory requirements.
• Supports Research and Development department testing.
• Other duties as assigned
What does it take to be successful?
• Degree in Engineering, Quality or a related field.
• Bachelor's degree and two years of technical experience or Associate's degree and five years of technical experience.
• Experience with inspection, testing, and troubleshooting.
• Experience in multiple types of international regulatory submissions (China, Korea, Saudi Arabia, Brazil, Australia, Columbia, Singapore, India, Taiwan, Malaysia, and Vietnam).
• Working knowledge of FDA, ISO, EU and other applicable regional regulations for handling complaints, reporting incidents, and implementing corrective and preventative actions.
• Knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC 16 2013, MHLW MO 169 and TG(MD)R Sch3 preferred.
Our Awesome Benefits!
Working for a growing innovative company like Argen means exciting opportunities for training and learning, career development and advancement from only the best in the dental industry. With all that hard work, Argen is committed to ensuring the welfare of its employees and provides an amazing benefit package that includes:
• Health/Dental/Vision Plans
• 401k with Employer Match
• Paid Vacation, Holiday and Sick Time
• Employee Events
• Wellness Programs
• Discounts for home, travel, entertainment, relaxation that includes Mobile phone service, Technology, Airline and Hotel, Theater/Theme Park tickets, Restaurants and so much more!
EOE/M/F/Vet/Disabled VEVRAA Federal Contractor
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