Sedana Medical · 1 week ago
Regulatory and Quality Director US
United States
Full-time
Remote
Director/Executive
10+ years expSedana Medical is a growing global MedTech and pharmaceutical company focused on inhaled sedation in intensive care. They are seeking an experienced Regulatory and Quality Director (US) to lead regulatory strategy and execution for their drug-device combination product, ensuring compliance and quality throughout its lifecycle.
Health CareMedicalMedical Device
Responsibilities
Lead U.S. regulatory strategy and execution for the NDA submission and FDA review of a drug-device combination product
Serve as a primary point of contact with the FDA, with hands-on engagement across CDER and CDRH
Provide strategic and operational regulatory support during the review process
Oversee U.S. post-approval regulatory and quality activities, including annual reports, safety updates, complaint handling, labeling changes, and compliance monitoring
Collaborate closely with Global Regulatory and Quality Assurance to ensure high-quality submissions and timely, effective responses to health authority questions
Provide regulatory and quality input to cross-functional teams (Clinical, Medical, Commercial, and others) to support U.S. development and commercialization activities
Monitor and interpret evolving U.S. regulations and guidance relevant to drug-device combination products
Support ex-U.S. regulatory strategy and interactions, including activities in Germany, Spain, France, and the UK
Contribute to regulatory intelligence, risk assessments, and mitigation planning across the portfolio
Qualification
Required
Advanced degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline
Minimum 10+ years of Regulatory Affairs experience and 2-5 years of Quality Assurance experience within the pharmaceutical and medical device industry
Significant hands-on experience with drug-device combination products; experience with Class II medical devices or higher is a plus
Demonstrated hands-on FDA experience, including direct interactions with CDER and CDRH
Proven ability to lead regulatory strategy from pre-submission through approval and post-market lifecycle management
Strong knowledge of U.S. FDA regulations and guidance for combination products familiarity with EMA and EU regulatory frameworks is an advantage
Excellent communication, collaboration, and stakeholder-management skills
Fluent in English, both written and spoken
Benefits
Competitive compensation and benefits package.
Company
Sedana Medical
The AnaConDa (Anaesthetic Conserving Device) is an anaesthetic delivery system
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Johan Spetz
CFO
Recent News
2025-11-24
2025-11-21
2025-05-06
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