Regulatory Affairs Specialist

A Charlotte, NC area based Medical company is searching for a Regulatory Affairs Specialist as they continue to grow. This role is based in Fort Mill, South Carolina and is the result of continued success, and sustained growth. The chosen applicant will collaborate with cross functional teams participating in projects to maintain and improve the Regulatory processes according to their internal Quality Systems and ensuring compliance with North America (USA and Canada) regulatory requirements.

Some 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

The ideal candidate will have:

• 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