Senior Regulatory Affairs Specialist

Job Summary

A company is looking for a Senior Regulatory Affairs Specialist (Remote).

Key Responsibilities

• Develop and implement regulatory strategies for timely approvals from global regulatory bodies
• Prepare and submit regulatory documentation for Class IIa, IIb, and III medical devices, including technical files and design dossiers
• Provide regulatory guidance to cross-functional teams and maintain relationships with regulatory agencies

Required Qualifications

• Bachelor's degree with a minimum of 4 years or an advanced degree with at least 2 years of regulatory experience in medical devices, biotech, or pharmaceuticals
• Experience with 21 CFR 820, ISO 13485, and EU Medical Device Regulations
• Knowledge of SaMD and Digital Health applications
• Experience in regulatory submissions for new products and changes
• Understanding of product development processes and design control related to medical device regulations