Regulatory Affairs Specialist

Overview

Support global regulatory activities for medical devices, including obtaining and maintaining approvals, preparing regulatory strategies, and addressing post-market changes.

What you'll do

• Determine requirements for product submissions and regulatory filings.
• Recommend regulatory pathways and strategies.
• Review documentation and evidence for regulatory compliance.
• Complete and maintain regulatory filings with internal and external teams.
• Write summary documentation and support responses to regulators.
• Review and substantiate product labeling and claims.
• Act as a regulatory resource and subject matter expert.

What you'll need

• At least 2 years of medical device regulatory affairs or quality assurance experience.
• B.A. or B.S. degree in a relevant life science, engineering, medical technology, regulatory science, or related field.
• Understanding of the current regulatory environment.
• Applied knowledge of FDA regulations and guidelines.
• Ability to evaluate information against standards, laws, and regulations.

Details

• Remote in the United States.
• Travel required up to 5%.
• Annual salary range: $79,000–$119,000.