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Regulatory Affairs Associate

South Bend, Indiana 46614 | Permanent Hire

Job ID: 7536 Industry: Industry Pay Rate: 60,000

Are you a Regulatory Affairs Specialist interested in a direct hire position in South Bend, IN?  Do you have at least 1 year of Regulatory Affairs experience?   If yes, then keep reading!


Top Reasons to Work for our Client:
  • One of the world’ s leading companies in their industry
  • Over 50 years’ experience
  • 20+ locations worldwide with more than 1500 employees


What’ s in it for you?
  • Competitive salary
  • Excellent benefits package including flexible schedule, outstanding health benefits, strong 401k match, paid life and disability insurance, fitness membership and tuition reimbursement, and exceptional PTO package.


What you will be doing?
  • Writing dossiers
  • Processing certificates & registration documents including 510(k) submissions and UDI’ s for US, and international locations
  • Update processes to ensure compliance with changes in ISO 13485 2016, FDA CFR21 Part 820 & MDSAP regulations.
  • Continually research regulations and ensure procedures are kept updated.


What you need for this position?
  • BS Degree
  • 1-3 years Regulatory Affairs or Quality Systems experience
  • Medical device industry experience
  • Knowledge of ISO 13485 MDSAP/CFR 21 Part 820
  • UDI and packaging review experience

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