Regulatory Affairs Specialist

3 weeks ago


Knoxville, Tennessee, United States Jobot Full time
Job Overview

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Jobot. As a key member of our Quality Assurance team, you will be responsible for ensuring compliance with regulatory requirements and maintaining our internal Quality Systems.

Key Responsibilities
  • Collaborate with cross-functional teams to maintain and improve Regulatory processes
  • Work with the QA/RA team on quality and regulatory issues due to customer complaints
  • Develop and implement strategies to ensure compliance with EU MDR, 21 CFR 820, and other regulatory bodies with a focus on FDA
  • Provide expertise on IEC62304, ISO14971, IEC62366, and ISO13485
Requirements
  • Minimum of five years of experience in Regulatory Affairs in the medical device industry
  • Strong knowledge and experience in understanding EU MDR, 21 CFR 820, and other regulatory bodies with a focus on FDA
  • Understanding of IEC62304, ISO14971, IEC62366, and ISO13485
What We Offer
  • 100% Employer paid Med, Dental, Vision
  • 4% match on 401K
  • 10 paid holidays and 3 weeks PTO to start, goes to 4 weeks after 1 year of employment
  • Flexible scheduling
  • Base salary of $100-120K
  • Relocation Assistance
  • 10% Bonus potential


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