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
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