Regulatory Affairs Specialist

24 hours ago


Fort Mill, South Carolina, United States Jobot Full time
Regulatory Affairs Specialist Opportunity

A leading medical company in Charlotte, NC is seeking a highly skilled Regulatory Affairs Specialist to join their team. This role is based in Fort Mill, South Carolina and involves collaborating with cross-functional teams to maintain and improve regulatory processes according to internal Quality Systems and ensuring compliance with North America (USA and Canada) regulatory requirements.

Key Responsibilities:
  • Apply design controls and ensure compliance with relevant standards
  • Collaborate with cross-functional teams to maintain and improve regulatory processes
  • Ensure compliance with North America (USA and Canada) regulatory requirements
  • Travel may be required
What We Offer:
  • Competitive base salary and overall compensation package
  • Full benefits: Medical, Dental, Vision
  • Generous PTO, vacation, sick, and holidays
  • Life Insurance coverage
  • 401(k) with generous company match
  • Flexible scheduling to assist with commutes and allow people to handle everyday affairs
Requirements:
  • 5 years of experience in Regulatory Affairs in the medical device industry
  • Experience applying design controls
  • Training in Quality Systems, QSRs and GMPs
  • Understanding of IEC62304, ISO14971, IEC62366, ISO13485, and other relevant standards
  • Excellent communication skills

Interested in learning more about this opportunity? Click the "Apply Now" button to submit your resume and take the first step towards a rewarding career with Jobot.



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