Executive Director

Role: Executive Director, Global Regulatory Affairs – Medical Devices & Combination Products Client: Global Biopharmaceutical Leader Salary Range: $238,000 - $374,000 + Executive Benefits & Incentives My client, a premier global R&D organization specializing in transformative specialty therapies, is seeking a visionary Executive Director of Global Regulatory Affairs (CMC). This is a high-impact leadership role as the organization’s primary subject matter expert for medical devices and drug-device combination products. The Opportunity: In this strategic leadership position, you will oversee a high-performing team of regulatory experts to streamline the global path to market for innovative device technologies. You will act as a bridge between multiple R&D functions—including clinical, quality, and manufacturing—to ensure that regulatory strategies are integrated, robust, and future-proof across major international markets (US, EU, UK, Japan, and China). Key Responsibilities: Strategic Leadership: Develop and execute global regulatory roadmaps for a diverse portfolio of devices and combination products, ensuring timely approvals and clearances (510(k), PMA, De Novo, CE marking/MDR). Cross-Functional Partnership: Collaborate with senior leadership in Quality, Clinical Development, Manufacturing, and Supply Chain to align usability, human factors, and risk management with global regulatory requirements. Global Advocacy: Serve as the primary liaison with major health authorities, including the FDA (CDRH/CDER/OCP), EMA/Notified Bodies under EU MDR, and other regional agencies. Risk & Compliance: Manage lifecycle compliance, overseeing technical documentation, vigilance, and post-market signals. Proactively mitigate risks associated with design controls and ISO 14971 standards. Policy & Insight: Monitor the evolving regulatory landscape (including cybersecurity and digital health) to translate emerging trends into actionable evidence-generation strategies. Business Development: Provide expert due diligence for M&A and licensing activities regarding device classifications and regulatory viability. Professional Qualifications: Education: Advanced degree in a Scientific or Engineering field (MS, PhD, or PharmD). Experience: 20+ years of total industry experience, with at least 10 years specifically in Regulatory Affairs focused on medical devices or combination products. Technical Mastery: Proven track record authoring and negotiating complex submissions (IDE, PMA, MDR Technical Documentation). Deep knowledge of ISO 13485, ISO 14971, and IEC 62304. Leadership: Demonstrated experience managing and developing senior-level teams and leading through influence in a matrixed environment. Communication: Exceptional negotiation and presentation skills, with the ability to simplify complex technical/clinical issues for executive stakeholders and regulators. Why Join This Team? This organization is a certified "Global Top Employer" known for a culture of inclusivity and innovation. You will play a pivotal role in delivering life-changing treatments to patients worldwide while benefiting from a hybrid work model and a comprehensive executive compensation package that includes short- and long-term incentives, robust health benefits, and significant retirement contributions. hybrid work model short- and long-term incentives robust health benefits significant retirement contributions My client is an Equal Opportunity Employer committed to a diverse and inclusive workforce. --- #J-18808-Ljbffr