Principal Regulatory Affairs Specialist

A company is looking for a Principal Regulatory Affairs Specialist (Remote). Key Responsibilities Collaborate with internal departments to meet regulatory requirements for product development and distribution Develop and update regulatory policies, strategies, and standard operating procedures (SOPs) Prepare, review, and submit regulatory submissions to authorities in various geographies Required Qualifications Minimum of 10 years of related experience with a Bachelor's degree, or 8 years with a Master's degree, or a PhD with 4 years of experience Degree in science, math, engineering, medical, or other technical fields preferred Experience with pre- and post-market medical device submissions Detailed knowledge of domestic and international regulatory guidelines and policies Some medical device software engineering background or experience preferred

Mar 13, 2025 - 15:14

A company is looking for a Principal Regulatory Affairs Specialist (Remote). Key Responsibilities Collaborate with internal departments to meet regulatory requirements for product development and distribution Develop and update regulatory policies, strategies, and standard operating procedures (SOPs) Prepare, review, and submit regulatory submissions to authorities in various geographies Required Qualifications Minimum of 10 years of related experience with a Bachelor's degree, or 8 years with a Master's degree, or a PhD with 4 years of experience Degree in science, math, engineering, medical, or other technical fields preferred Experience with pre- and post-market medical device submissions Detailed knowledge of domestic and international regulatory guidelines and policies Some medical device software engineering background or experience preferred