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.