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Senior Regulatory Affairs Specialist

3 months ago

Princeton, United States Intellectt Inc Full time

Role: Senior Regulatory Affairs Specialist

Location: Princeton, NJ 08540

Duration: 12 Months


Key Responsibilities:

  • Collaborate with multiple business units to develop, update, and enhance regulatory affairs processes.
  • Assist in strategy implementation and operations for regulatory affairs, including product registration submissions, progress reports, and amendments.
  • Update and create procedures to align with changes in the regulatory landscape, particularly EU MDR.
  • Identify opportunities for process improvement in regulatory affairs and drive changes to completion.


Skills Required:

  • Proficient in EU MDR
  • Knowledgeable in Regulatory Change Assessment
  • Experience with US and EU medical device submissions
  • Skilled in supporting internal and external inspections
  • Ability to work cross-functionally in a matrixed environment
  • Experience in continuous improvement activities


Education & Experience:

  • Bachelor’s Degree required
  • 3-5 years in Medical Device Regulatory Affairs