Regulatory Affairs Specialist

4 days ago


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

A leading medical device company is seeking a highly skilled Regulatory Affairs Specialist to join their team. This is an exciting opportunity to work with a dynamic company that is committed to delivering innovative medical solutions.

Key Responsibilities
  • Collaborate with cross-functional teams to maintain and improve regulatory processes and ensure compliance with North American regulatory requirements.
  • Develop and implement regulatory strategies to support product development and commercialization.
  • Provide regulatory guidance and support to internal stakeholders to ensure compliance with regulatory requirements.
  • Stay up-to-date with changing regulatory requirements and industry trends.
Requirements
  • 5 years of experience in Regulatory Affairs in the medical device industry.
  • Experience applying design controls and training in Quality Systems, QSRs, and GMPs.
  • Understanding of IEC 62304, ISO 14971, IEC 62366, ISO 13485, and other relevant standards.
  • Excellent communication and interpersonal skills.
What We Offer
  • Competitive base salary and overall compensation package.
  • Full benefits, including medical, dental, and vision coverage.
  • Generous PTO, vacation, sick, and holiday time.
  • Life insurance coverage.
  • 401(k) with generous company match.
  • Flexible scheduling to support work-life balance.


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