Senior Regulatory Affairs Specialist

This role will provide business-aligned guidance focused on governance, compliance, and operational risk management. You will partner with leaders, compliance stakeholders, and cross-functional teams to translate complex issues into practical recommendations, strengthening responsible execution, improving decision-making, and supporting sustainable growth within a healthcare environment.

Location: Remote - US based candidates only, no visa sponsorship available.

Responsibilities

• Lead regulatory strategy for product lifecycles in SaMD
• Support regulatory operations for product development and launch phases
• Prepare and manage regulatory submissions and correspondences
• Maintain comprehensive regulatory documentation and trackers
• Assess design changes for regulatory filing impacts
• Monitor and report on submission milestones and required filings
• Collaborate with teams to enhance regulatory processes and tools

Qualifications

• Bachelor's degree in a scientific, engineering, healthcare, or related field
• 5+ years in regulatory affairs or operations for medical devices or digital health
• Experience with software-based medical products (SaMD)
• Familiarity with FDA regulations, EU MDR, and ISO standards
• Strong documentation, project coordination, and organizational skills

Benefits

• Competitive salary and equity packages
• Comprehensive health, dental, and vision insurance
• Mental health resources and wellness support
• Employee discounts for friends & family
• 20 days of paid time off, 8 flexible wellness days, and 13 holidays
• Paid sick leave and parental leave

Pay

$151,300 – $178,000 annually