Manager, Regulatory Affairs

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. The position offers the opportunity to strengthen responsible execution, improve decision-making, and support sustainable growth within a healthcare environment.

Responsibilities

• Develop and execute regulatory strategies for medical devices
• Manage and guide regulatory associates on team tasks
• Lead FDA submissions for medical devices and SaMD products
• Serve as the Regulatory Subject Matter Expert (SME) and approve promotional materials for compliance
• Handle EU MDR technical documentation and international submissions
• Create tools to enhance team efficiency in regulatory processes
• Collaborate on processes ensuring compliance for AI and cybersecurity products

Qualifications

• BA or BS in engineering, life sciences, or related field required
• 8-10 years of US/EU regulatory affairs experience (6 years with a Master's degree)
• Demonstrated competency under 21 CFR 820, EU MDD/MDR, ISO 13485 and other industry standards
• Experience with Software as a Medical Device (SaMD) required
• New product development experience required
• Authored 510(k)s and managed FDA reviews for clearance

Benefits

• Medical, dental, and vision insurance
• Paid holidays and paid time off
• 401K with company match
• Employee Stock Purchase Plan
• Annual organizational and cultural committee events

Pay

$127,000 – $165,000 annually

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