Regulatory Affairs Specialist

2 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 develop and implement regulatory strategies
  • Work with the QA/RA team to resolve quality and regulatory issues related to customer complaints
  • Develop and maintain knowledge of regulatory requirements, including EU MDR, 21 CFR 820, and other relevant regulations
  • Contribute to the development and implementation of quality and regulatory procedures
Requirements
  • Minimum of five years of experience in Regulatory Affairs in the medical device industry
  • Strong knowledge of regulatory requirements, including EU MDR, 21 CFR 820, and other relevant regulations
  • Excellent communication and collaboration skills
  • Ability to work in a fast-paced environment and prioritize multiple tasks
What We Offer
  • 100% Employer-paid medical, dental, and vision benefits
  • 4% match on 401(k) plan
  • 10 paid holidays and 3 weeks of PTO to start, increasing to 4 weeks after one year of employment
  • Flexible scheduling
  • Base salary of $100,000 - $120,000 per year
  • Relocation assistance
  • 10% bonus potential


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