Dental Regulatory Affairs Associate

Website Keystone Industries

Position Overview

The Dental Regulatory Affairs Associate possesses and maintains up-to-date knowledge of regulatory requirements relative to products and areas of responsibility as assigned. Responsible for electronic registration activities, maintenance of Safety Data Sheets and provides support for regulatory related submission activities.

Essential Job Functions

  • Assist QA/Regulatory personnel with preparing FDA, Health Canada, EU and other regulatory data submissions
    • Assist with researching global regulatory requirements
  • Assist with determining regulatory pathways for new product development
  • Regulatory Requests:
    • Generate, request, and obtain regulatory certificates (Certificates of Foreign Government/Certificates of Pharmaceutical Product, etc.)
    • Apostille of Regulatory statements and certificates
    • Completion of customer surveys and/or questionnaires
    • Generation of Safety Data Sheets
  • Assist with internal/external audits
  • Assist with inspections by Regulatory Agencies and Notified Bodies
  • Assist with maintaining NDC listings database, medical device registrations and establishment registrations – updating listings as necessary
  • Assist with updating product labels and ensure products are appropriately classified under GHS requirementsAdditional Job Functions:
  • Help to ensure the company meets all requirements established by U.S., Canadian and other international government agencies for medical device, pharmaceutical and other products being sold into the U.S. and international markets
  • Respond to customer, government official and company personnel requests for technical data, product or quality system certificates and other information to enable them to meet regulatory requirements. Perform research and prepare documents as needed
  • Assist with customer complaint and product nonconformance follow-up and close-out activities including completion of forms, Product Conformance Investigations, Corrective Action Requests, Nonconformance Product Reports, etc.
  • Assist with quality audits including preparation of audit plans and checklists, performing internal/external audits and composing audit reports
  • Perform follow-up audit activities as necessary to ensure non-conformances are corrected and documentation is complete
  • Prepare, update and maintain product information and technical files, Device Master Records, product design/development records, etc.
  • Maintain quality system records to ensure compliance according to regulatory requirementsQualifications
  •  
  • 2 years relevant experience in a regulated technical function, including medical devices and drugs
  • Strong interpersonal skills-ability to interface and communicate/collaborate at all levels internally and externally
  • Adept verbal and written communication skills-including technical writing & documentation
  • High attention to detail
  • Highly organized and strong project management skills
  • Strong computer skills and proficiency in Microsoft Office applications (Outlook, Excel, Word, PowerPoint)
  • Strong problem solving and multi-tasking skills

 

Desired Skills

  • Knowledge of cGMP requirements, ISO standards and/or quality assurance
  • Previous experience in a regulated function (e.g. quality assurance, quality control, research, etc.)
    • Familiarity with international market labeling and registrations
    • Knowledge of OSHA, EU CLP, and GHS labelling and SDS requirements
  • Experience using Intelligent Authoring (or similar service) for document generation

 

Education/Certifications:

    • High School Graduate
    • Bachelor’s Degree in a science/chemistry-related field desirable

To apply for this job email your resume in Word or PDF format to careers@keystoneind.com

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