Overview
Regulatory Affairs Specialist Jobs in Irvine, CA at Glidewell Dental
Title: Regulatory Affairs Specialist
Company: Glidewell Dental
Location: Irvine, CA
Essential Functions:
Serves as Regulatory Affairs subject matter expert (SME) on designated projects and product development to ensure compliance through all phases of development.
Provides project and product guidance, feedback, and recommendations as necessary to support compliance.
Participates in development meetings and collaborates with appropriate project teams on any issues of non-compliance.
Determines requirement and prepares and submits company registrations for State Licensing/Permits accordingly.
Prepares, submits, and oversees designated product registrations and (510(k)) submissions to FDA and other regulatory bodies.
Prepares, submits, and oversees designated domestic and international submissions.
Serves as point contact for FDA, regulatory bodies, and various agencies during submission processing and review to resolve inquiries and increase approval effort.
Serves as co-author for 510(k) submissions, partnering with appropriate team members on complex submission and providing insight as necessary to support clearance.
Monitors compliance with existing regulations/standards/guidance and upcoming or changing regulations/standards/guidance.
Reviews and approves design control documents.
Evaluates compliance with applicable regulations, project policies, and procedures.
Reviews and writes standard operating procedures (SOPs) and other RA policies as necessary.
Collaborates with technical staff to foster understanding of SOPs and guidance documentation.
Coordinates with international regulatory team members regarding product changes and regulatory notification and/or approval requirements.
Provides management with ideas for developing and implementing strategies and processes.
Reviews and approves advertisements, labels, and public communication documents for regulatory compliance.
Reports significant regulatory issues related to a product’s release to appropriate parties.
Evaluates product compliance to applicable regulations and project requirements.
Participates in FDA facility inspection, Notified Body audits, and other government inspections as needed.
Maintains RA related files.
Maintains company registrations and device listings in the US, Canada, and other countries.
Performs other related duties and projects as business needs require at direction of management.
Knowledge and Abilities:
Proficient knowledge of general office procedures.
Proficient skills in the MS Office Suite (Excel, Word, PowerPoint, and Outlook).
Proficient quantitative and analytical skills.
Demonstrated prioritization and time management skills.
Demonstrated knowledge and understanding of related State and Federal regulations and procedures.
Demonstrated high standard of quality of work.
Demonstrated knowledge of FDA 510(k) and ISO 13485 Standards.
Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg. Practice, Good Practices training programs, SOP development, and GMP audits and inspections).
Demonstrated reliability, dependability, and flexibility in work habits.
Demonstrated attention to detail and accuracy.
Ability to prioritize and organize project tasks and goals effectively.
Ability to maintain confidentiality, exhibiting high level of integrity,
Education and Experience:
Bachelor’s degree in related field preferred, but not required.
Minimum two (2) years of experience in Regulatory Affairs.
Experience preparing (writing) domestic and international product submissions, required.
Pay Range:
$68,000 – $90,000/YR
