Regulatory Affairs Specialist

Ultradent

Not specified
Regulatory agency specifications
Internal documentation development
Product technical documentation
Ultradent is seeking a Regulatory Affairs Specialist to manage regulatory submissions and ensure compliance with global market entry standards in the oral health sector. The ideal candidate will have a background in regulatory affairs, strong communication skills, and the ability to work independently as well as in cross-functional teams

Job Summary

  • Regulatory Affairs Specialist performs specialized work assignments relative to the analysis, evaluation, preparation and submission of documentation to regulatory agency specifications for global market entry.
  • You will also be responsible for development, review, and maintenance of internal documentation and encourage safe practices and enforce safety policies.
  • Participate in project teams to develop regulatory strategies, testing requirements, and other documentation to ensure that new product regulatory submissions meet the company’s product launch timelines in all identified markets.

Matching Summary

Match Score: 85

Ultradent is seeking a Regulatory Affairs Specialist to manage regulatory submissions and ensure compliance with global market entry standards in the oral health sector. The ideal candidate will have a background in regulatory affairs, strong communication skills, and the ability to work independently as well as in cross-functional teams.

Skills & Requirements

Must-have

  • Regulatory agency specifications
  • Internal documentation development
  • Product technical documentation
  • Current regulations and guidance
  • Product labeling review
  • Promotional materials review
  • Standard operating procedures

Nice-to-have

  • Cross-functional team setting
  • Global culture
  • Core values
  • Inclusive environment

Key Requirements

  • 2-year minimum work experience in regulatory affairs
  • 4 years minimum work experience in regulatory affairs
  • Bachelor’s degree
  • Experience submitting premarket submissions to the FDA (510(k))
  • Submitted EU Technical Documentation to a Notified Body

Work Rights

Not specified

Tailored Resume

Cover Letter