Regulatory Affairs Specialist

This Jobot Job is hosted by: Ryan Sullivan

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Salary: $100,000 - $120,000 per year

A rapidly growing Medical Device company in Charlotte, NC is currently hiring for a Regulatory Affairs Specialist (relocation considered)

• 100% Employer paid Med, Dental, Vision
• 4% match on 401K
• 10 paid holidays and 3 weeks PTO to start, goes to 4 weeks after 1 year of employment
• Flexible scheduling
• Base salary of 100-120K
• Relocation Assistance
• 10% Bonus potential

• Collaborate with cross functional teams participating in projects to maintain and improve the Regulatory processes according our internal Quality Systems and ensuring compliance with regulatory requirements
• Work with others on the QA/RA team on quality and regulatory issues due to customer complaints
• Minimum of five years of experience in Regulatory Affairs in the medical device industry
• Strong knowledge and experience in understanding EU MDR, 21 CFR 820, and other regulatory bodies with focus on FDA
• Understanding of IEC62304, ISO14971, IEC62366, ISO13485

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