Sr. Regulatory Affairs Specialist Job at PRISMATIK DENTALCRAFT, INC., Irvine, CA

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  • PRISMATIK DENTALCRAFT, INC.
  • Irvine, CA

Job Description

Prismatik Dentalcraft is a division of Glidewell Dental.

Essential Functions :

  • Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies.
  • Maintains company registrations and device listings in the US, Canada, and the EU.
  • Analyzes and reports department metrics.
  • Supports and maintains technical files, MDD certifications, and declarations of conformity in support of EU product registrations/CE mark.
  • Informs coordinator of product recalls.
  • Performs and supports internal, external, and third-party audits.
  • Maintains knowledge on current regulations and guidelines.
  • Evaluates compliance with applicable regulations, project policies, and procedures
  • Reviews and writes standard operating procedures (SOPs) and other RA/QA policies as necessary.
  • Collaborates with technical staff to foster understanding of SOPs and guidance documentation.
  • Composes audit plans and reports.
  • Conducts audits and inspections of GMP and non-regulated documentation.
  • Tracks internal and external corrective and preventive actions.
  • 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 negotiation abilities.
  • Demonstrated knowledge and understanding of related State and Federal regulations and procedures.
  • Demonstrated high standard of quality of work.
  • Demonstrated knowledge of FDA 510K 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 analyze and collate data for presentations and reports.
  • Ability to prioritize and organize project tasks and goals effectively.
  • Ability to maintain confidentiality, exhibiting high level of integrity, and trustworthiness.
  • Ability to interpret and collate data to present an accurate picture of market potential.
  • Ability to research new and emerging technologies and practices.
  • Ability to read technical diagrams, graphs, and instructions.

Education and Experience:

  • Bachelor’s degree in related field preferred
  • Minimum five (5) years of experience in Regulatory Affairs.
  • Minimum two (2) years of experience in software-based medical devices (e.g., SaMD or SiMD).
  • Experience in preparing (writing) domestic and international product submissions, required.

Pay Range: $86,000 - $120,000/YR

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