Job Description
📋 Description Provide regulatory guidance to product teams, develop regulatory plans, and review and approve Determine regulatory pathways and formulate regulatory strategies for the U.S. and Canadian Author and lead regulatory documentation and submissions, including U.S. FDA 510(k) premarket Coordinate with technical experts to provide additional data requested by regulatory agencies and Provide risk-based regulatory input to projects and issues, ensuring cross-functional alignment and Collaborate with international counterparts to support global regulatory submissions, approvals 🎯 Requirements Minimum 8 years of regulatory affairs experience in a medical device company; may include In-depth understanding of US Medical Device regulations, Health Canada guidance, and EU MDR. Regulatory knowledge of product lifecycle management, design controls, risk management Ability to work in a fast-paced environment and manage multiple projects simultaneously. Strong verbal and written communication skills; ability to translate technical documentation into Minimum BS or higher in Biomedical, Electrical, or Mechanical Engineering, or Pharmacy 🎁 Benefits Intuitive is an Equal Opportunity Employer. Market-competitive compensation packages, including base pay, incentives, benefits, and equity. Some roles may require vaccination proof; details vary by role.
