Regulatory Affairs Specialist

1 week ago


Fort Mill, South Carolina, United States Jobot Full time
Job Title: Regulatory Affairs Specialist

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 is a result of the company's continued success and growth.

About the Role:

The successful candidate will collaborate with cross-functional teams to maintain and improve the company's Regulatory processes according to their internal Quality Systems and ensure compliance with North America (USA and Canada) regulatory requirements.

Responsibilities:
  • Develop and implement Regulatory strategies to ensure compliance with relevant regulations and standards.
  • Collaborate with cross-functional teams to maintain and improve the company's Quality Systems.
  • Ensure compliance with North America (USA and Canada) regulatory requirements.
  • Develop and maintain relationships with regulatory agencies and industry partners.
  • Provide training and support to colleagues on Regulatory matters.
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.
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.


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