Regulatory Affairs Manager
Danvers, MA, 01923
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
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