Sr. Regulatory Affairs Specialist II

About the role

The Senior Regulatory Affairs Specialist II will work with Product Development, Quality, Operations, and Marketing to support the product development process and ensure compliance with regulatory requirements.

Responsibilities

• Serve as the Regulatory representative for project teams.
• Author US FDA premarket submissions (510(k), Q-submissions) and international filings.
• Serve as the primary contact for regulatory agencies and negotiate data requirements.
• Collaborate with Marketing and Legal for review of promotional materials and labeling.
• Monitor regulatory landscape changes and perform impact assessments.
• Maintain US FDA registrations, device listings, and UDI database requirements.
• Support internal and external audits.
• Mentor junior staff and develop new regulatory processes.

Requirements

• Bachelor’s degree in Engineering, Science, or relevant technical discipline.
• Minimum of 7 years of Regulatory Affairs experience.
• At least 5 years in a medical device company (US FDA Class II).
• RAC certification preferred.