Regulatory Project Manager

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Home office stipend
• Paid time off
• Vision insurance

About the Role:
Leading regulatory strategic and operational initiatives as a key partner to the medical device team. Assisting with driving projects forward, identifying new business opportunities from within existing clients, mitigating risks, and driving alignment across departments while ensuring projects are delivered on time, within scope, and budget. 



Responsibilities:

• Assist with the development of regulatory plans, prepare and submit to CDRH via eSTAR (and whatever the drug equivalent) prepare FDA presentation meeting slides, write FDA Pre-Submission meeting notes. 
• Register clients with the US FDA and list products.
• Assist clients with UDI requirements.
• Lead and manage cross-functional medical device development projects from discovery through commercialization, ensuring regulatory and clinical development alignment with client and organizational objectives.
• Coordinate and facilitate collaboration among stakeholders to ensure successful project execution.
• Monitor project progress, budget spend, identify risks, dependencies, and bottlenecks, and implement mitigation strategies to maintain project timelines and deliverables.
• Prepare product description and background information sections of the Regulatory Assessments, Pre-Submission requests, Breakthrough Device Designation, Premarket Notification submissions.
• Conduct scientific, medical and FDA research to support clients.
• Serve as the primary point of contact for medical device clients and internal stakeholders, providing regular project updates, recommendations, and executive-level reporting.
• Provide cross coverage regulatory support to the drug team as needed.
• Manage multiple projects simultaneously, ensuring deliverables are completed on time, within scope, within budget, and in compliance with quality and regulatory requirements.
• Support clinical and product development activities, including study planning, regulatory submissions and meetings, and commercialization readiness.
• Assist with strategic vendor introductions.
• Prepare and present project reports, dashboards, and strategic recommendations to clients, leadership, and cross-functional teams.
• Monitor project expenditures and resource utilization, identify budget variances, and recommend corrective actions as needed.
• Identify opportunities for additional services, business growth, and process enhancements within existing client programs.
• Build and maintain strong relationships with clients, external partners, and internal stakeholders to support long-term project and business success.
• Contribute to strategic planning, organizational initiatives, proposal development, and other special projects as assigned.
  
  

Requirements:

• Bachelor's degree in Life Sciences, Biotechnology, Engineering, Business, Project Management, or a related field; advanced degree (MS, MBA, PhD, or equivalent) preferred.
• RAC certification, preferred.
• 5+ years of regulatory project management experience with medical devices, diagnostics, pharmaceutical, CRO or other regulated life sciences environments.
• Demonstrated knowledge of medical device and drug FDA development processes, including product development, analytic testing, clinical research, regulatory meetings and submissions, quality systems, and commercialization activities.
• Strong writing and communication skills. 
• Strong project management expertise, including planning, scheduling, budgeting, resource management, risk assessment, and execution of complex cross-functional projects.
• Proven ability to manage multiple priorities simultaneously while delivering quality projects on time, within scope, and within budget.
• Strong analytical, problem-solving, and critical-thinking skills with the ability to translate complex information into actionable recommendations.
• Excellent verbal, written, presentation, and interpersonal communication skills, with the ability to effectively engage clients, executives, scientists, clinicians, and regulatory professionals.
• Knowledge of applicable regulatory requirements and industry standards, including FDA regulations, GCP, GMP, GLP, QMSR standards, and other relevant compliance frameworks.
• Experience utilizing project management tools and business software, including Smartsheet, and advanced proficiency in Microsoft Office Suite (Excel, PowerPoint, Word, Outlook).
• Strong organizational, time management, and executive functioning skills with the ability to work independently, manage competing deadlines, and prioritize projects.
• Customer-focused mindset with a commitment to quality, operational excellence, continuous improvement, and exceptional service delivery.
  
  
   
  
  
  

This is a remote position.