Director, International Regulatory Affairs
Accountabilities: Define and oversee global regulatory strategies for the product portfolio, ensuring alignment with business priorities, regulatory requirements, and international commercialization objectives.
Lead regulatory strategy for commercialization across key international markets, including the EU, Asia-Pacific, Middle East, and UK.
Direct the development, preparation, review, and execution of international regulatory submissions, product registrations, approvals, and lifecycle activities.
Establish filing strategies, submission plans, timelines, dependencies, governance processes, and post-approval activities required to support international market expansion.
Partner with executive leadership and cross-functional teams across R&D, Quality, Clinical, Commercial, and Manufacturing to integrate regulatory considerations into portfolio and enterprise decision-making.
Maintain readiness for regulatory inspections, audits, health authority interactions, and high-level regulatory negotiations across global markets.
Monitor international regulatory developments and policy changes, assess potential business impact, and develop proactive organizational responses.
Oversee regional regulatory records, registrations, commitments, and submission systems, including applicable European, Middle Eastern, and other international regulatory databases.
Influence regulatory policy and industry standards through participation in professional forums, standards bodies, and regulatory working groups.
Champion regulatory transformation initiatives involving digital enablement, automation, process modernization, and improved enterprise regulatory systems.
Prepare executive-level regulatory materials, presentations, and recommendations to support portfolio decisions and strategic business priorities.
Develop regulatory talent and contribute to building a strong, future-ready global regulatory organization.
Support additional strategic initiatives and cross-functional priorities as business and regulatory needs evolve.
Requirements:
Advanced degree in molecular biology, genomics, diagnostics, or a closely related discipline; a PhD is preferred.
15+ years of relevant regulatory affairs or industry experience, with alternative experience thresholds based on advanced degree level.
Demonstrated success leading enterprise-level regulatory strategies and high-impact submissions, particularly within international diagnostics or medical device commercialization.
Extensive experience engaging with senior leaders at global regulatory agencies and influencing international regulatory policy.
Strong knowledge of international medical device and diagnostic regulatory frameworks, including IVDD, IVDR, FDA 21 CFR, and UK MDR 2002.
Working knowledge of GMP quality systems and relevant standards such as ISO 13485 and risk-management frameworks such as ISO 14971.
Familiarity with clinical laboratory regulations and standards, including CAP, CLIA, NYSDOH, and ISO 15189.
Understanding of privacy and protected health information requirements, including HIPAA and GDPR.
Knowledge of regulated clinical study requirements, including ICH E6/GCP, ISO 20916, FDA 21 CFR Parts 11, 50, 54, and 56.
Proven ability to manage complex international submission pathways, product registrations, compliance requirements, and post-approval commitments.
Strong portfolio and enterprise decision-making skills, with the ability to balance regulatory risk, innovation, patient needs, and commercial priorities.
Exceptional communication, executive presence, stakeholder management, influencing, and negotiation skills.
Advanced proficiency with regulatory information management systems, global submission platforms, and compliance technologies.
Ability to operate effectively across multiple time zones and respond to urgent international regulatory matters.
Willingness and ability to travel domestically and internationally as required.
Adaptability and willingness to take on evolving responsibilities, technologies, and cross-functional initiatives.
Benefits:
Base salary: $169,000–$242,000 annually in the United States, with actual compensation determined by qualifications, experience, and location.
Potential eligibility for additional compensation, including annual bonuses and/or incentive programs.
Comprehensive medical, dental, and vision coverage.
401(k) retirement plan with employer matching.
Flexible time-off or vacation benefits.
Mindfulness and employee well-being programs.
Remote work opportunity in the United States.
Broad international scope with opportunities to influence regulatory strategy and healthcare innovation globally.
Leadership exposure and opportunities for professional and organizational growth.
Opportunities to represent the organization in regulatory negotiations, industry forums, standards bodies, and international working groups.
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