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Regulatory Affairs Specialist – Medical Device

TekOne IT Services Pvt. Ltd.
Princeton, NJ Contractor
POSTED ON 3/20/2025
AVAILABLE BEFORE 4/20/2025
Role: Regulatory Affairs Specialist – Medical Device

Location:
Princeton, NJ 08540

Duration: 12 Months on W2 (On-Site)

Experience

  • Min. 3 years in Medical Device Regulatory Affairs
  • Experience with IVD Devices in Regulatory Affairs
  • Experience with US 510(k) submission in the last years

Skills

  • Knowledge of EU MDR
  • Experience with regulatory change assessments
  • Proficiency in US and EU medical device submissions
  • Support for internal and external inspections
  • Ability to work cross-functionally in a matrixed environment
  • Excellent technical writing skills
  • Good communication skills

Education

  • BA Degree required

Duties

  • Collaborate with business units to enhance regulatory processes
  • Assist in strategy implementation for regulatory activities
  • Develop product registration submissions and related documentation
  • Update procedures to align with regulatory changes, including EU MDR
  • Identify and implement opportunities for process improvement

Additional Requirements

  • Technical writing examples preferred

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