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 ManagerLocation-Type: Remote (U.S.)Start Date Is: ASAPDuration: 6-Month Contract (extension potential)Compensation Range: $90/hr - $105/hrJob 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 devicesReview and assess requirements, design documentation, test protocols, and risk management filesProvide regulatory guidance on cybersecurity, software, and device-to-cloud architecturesEvaluate documentation for FDA readiness and complianceContribute to and review 510(k), PMA, IDE, and 514(b)-related submissionsSupport risk assessments, user needs analyses, and misuse scenario evaluationsCollaborate with engineering and product teams to ensure regulatory alignment throughout developmentParticipate in regulatory problem-solving discussions and resolution strategiesInterface with regulatory agencies and support submission-related communicationsDrive documentation quality and compliance across the product lifecycleRequirements: Must-Haves: 5-8+ years of Regulatory Affairs experience within the medical device industryExperience supporting Class II and/or Class III medical device submissionsHands-on experience authoring, reviewing, or leading 510(k), PMA, IDE, or 514(b) submissionsExperience 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 complianceExperience with connected device ecosystems that stream data from devices to the cloudDeep experience reviewing risk assessments, user needs, misuse scenarios, and regulatory documentationAbility to work independently with minimal oversightStrong regulatory writing, communication, and stakeholder management skillsExperience reviewing and providing feedback on cross-functional documentationExperience within highly regulated medical device environmentsNice-to-Haves: Experience with FDA cybersecurity requirements under Section 524B after 2022Experience supporting cybersecurity submission content from 2024-2026Prior exposure to FDA Warning Letters and remediation effortsExperience in cardiovascular, diabetes, robotics, neuromodulation, or other complex digital health ecosystemsRAC certificationAI/ML or Predetermined Change Control Plan (PCCP) experienceExperience helping organizations transition to more mature regulatory and quality frameworksBenefits: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