Regulatory Affairs Manager

Apply now: Digital Health Regulatory Affairs Manager , location is Remote (U.S. - East Coast hours preferred) . The start date is ASAP for this 6-month contract position with strong extension potential.


Job Title: Digital Health Regulatory Affairs Manager
Location-Type: Remote (U.S.)
Start Date Is: ASAP
Duration: 6-Month Contract (extension potential)
Compensation Range: $90/hr - $105/hr

Job Description:
The client is seeking a senior Regulatory Affairs professional to independently lead regulatory activities supporting cloud-connected medical device ecosystems, software-enabled devices, cybersecurity initiatives, and FDA submissions for Class II and Class III products. The ideal candidate will provide strategic regulatory guidance, ensure FDA readiness, and partner cross-functionally across product development, quality, engineering, and risk management teams.

Day-to-Day Responsibilities:

• Lead regulatory strategy and submission activities for connected medical devices
• Review and assess requirements, design documentation, test protocols, and risk management files
• Provide regulatory guidance on cybersecurity, software, and device-to-cloud architectures
• Evaluate documentation for FDA readiness and compliance
• Contribute to and review 510(k), PMA, IDE, and 514(b)-related submissions
• Support risk assessments, user needs analyses, and misuse scenario evaluations
• Collaborate with engineering and product teams to ensure regulatory alignment throughout development
• Participate in regulatory problem-solving discussions and resolution strategies
• Interface with regulatory agencies and support submission-related communications
• Drive documentation quality and compliance across the product lifecycle

Requirements:

• Must-Haves:
  • 5-8+ years of Regulatory Affairs experience within the medical device industry
  • Experience supporting Class II and/or Class III medical device submissions
  • Hands-on experience authoring, reviewing, or leading 510(k), PMA, IDE, or 514(b) submissions
  • Experience with Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD)
  • Strong knowledge of FDA regulations, ISO 14971 risk management, and cybersecurity compliance
  • Experience with connected device ecosystems that stream data from devices to the cloud
  • Deep experience reviewing risk assessments, user needs, misuse scenarios, and regulatory documentation
  • Ability to work independently with minimal oversight
  • Strong regulatory writing, communication, and stakeholder management skills
  • Experience reviewing and providing feedback on cross-functional documentation
  • Experience within highly regulated medical device environments
• Nice-to-Haves:
  • Experience with FDA cybersecurity requirements under Section 524B after 2022
  • Experience supporting cybersecurity submission content from 2024-2026
  • Prior exposure to FDA Warning Letters and remediation efforts
  • Experience in cardiovascular, diabetes, robotics, neuromodulation, or other complex digital health ecosystems
  • RAC certification
  • AI/ML or Predetermined Change Control Plan (PCCP) experience
  • Experience helping organizations transition to more mature regulatory and quality frameworks

Benefits:

This role is eligible to enroll in both Mondo's health insurance plan and retirement plan. Mondo defers to the applicable State or local law for paid sick leave eligibility