Senior Regulatory Affairs Specialist

📋 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.