Regulatory Affairs Specialist

1 week ago


Fort Mill, South Carolina, United States Jobot Full time
About the Role

We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Fort Mill, South Carolina. As a key member of our cross-functional team, you will play a critical role in maintaining and improving our Regulatory processes to ensure compliance with North America (USA and Canada) regulatory requirements.

Key Responsibilities
  • Collaborate with cross-functional teams to develop and implement Regulatory strategies and processes
  • Ensure compliance with Quality Systems, QSRs, and GMPs
  • Apply design controls and relevant standards, including IEC62304, ISO14971, IEC62366, and ISO13485
  • Develop and maintain Regulatory documentation and records
  • Communicate effectively with internal stakeholders and external partners
What We Offer
  • Competitive base salary and overall compensation package
  • Full benefits, including Medical, Dental, Vision, and Life Insurance
  • Generous PTO, vacation, sick, and holidays
  • 401(k) with company match
  • Flexible scheduling to support work-life balance
Requirements
  • 5+ years of experience in Regulatory Affairs in the medical device industry
  • Proven track record of ensuring Regulatory compliance
  • Excellent communication and collaboration skills
  • Strong understanding of Quality Systems, QSRs, and GMPs
Why Choose Us?

At Jobot, we offer a dynamic and supportive work environment that fosters growth and development. If you are a motivated and detail-oriented Regulatory Affairs Specialist looking for a new challenge, we encourage you to apply.



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