Senior Regulatory Affairs Specialist

Location: Atlanta Area, GA

Job Type: Full-Time, Permanent

About the Role


We are seeking an experienced Senior Regulatory Affairs Specialist to join our team. This role is responsible for ensuring compliance with U.S. and EU medical device regulations throughout the product lifecycle. The ideal candidate will have strong expertise in regulatory submissions, technical documentation, and post-market compliance.

Key Responsibilities

• Develop and implement regulatory strategies for medical devices in compliance with U.S. and EU regulations.
• Prepare and maintain STED technical files for CE marking and liaise with notified bodies for EU MDR compliance.
• Manage and support 510(k) submissions, including change assessments.
• Oversee post-market activities, including labeling reviews and corrective actions.
• Independently draft technical documentation related to design changes and regulatory notifications.
• Collaborate with internal teams, external auditors, and regulatory agencies to ensure compliance.

Qualifications & Experience

Required:

• Bachelor's degree in a relevant scientific field.
• Minimum of 5+ years of experience in regulatory affairs, specifically in the medical device industry.
• Strong knowledge of U.S. FDA regulations, EU MDR, 510(k) submissions, Article 120, and STED files .
• Excellent technical writing and organizational skills.

Preferred:

• Regulatory Affairs Certification (RAC).
• Experience preparing technical files and STED submissions.
• Willingness to travel occasionally (up to 15%) to Malaysia.

This is an excellent opportunity for a regulatory affairs professional to contribute to a dynamic team and play a key role in ensuring global compliance for innovative medical devices.


If you meet the qualifications and are looking for a challenging and rewarding career, apply today!