Executive Director

Role Overview

Executive Director, Global Regulatory Affairs -- Medical Devices & Combination Products

Location: Boston, MA (Hybrid) 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 leader for this high-impact role. You will serve 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.

My client is an Equal Opportunity Employer committed to a diverse and inclusive workforce.

To apply or learn more, please submit your resume for a confidential discussion.