Principal Regulatory Affairs Specialist

A company is looking for a Principal Regulatory Affairs Specialist.

Key Responsibilities

Develop and implement global regulatory strategies for product registrations and compliance

Serve as regulatory lead on product development teams and provide input throughout the product lifecycle

Support and participate in audits and regulatory agency inspections

Required Qualifications

Bachelor of Science degree

At least 8 years of regulatory affairs experience in the medical device industry

Current experience leading multiple successful 510(k) clearances and CE marking

Experience with digital health and Software as a Medical Device (SaMD)

Knowledge of ISO 13485, FDA regulations, and EU MDR