Director, International Regulatory Affairs

New

GRAILDiagnostics, healthcare

This role could be based either in Sunnyvale, DC or RTP., Requires flexibility to operate across multiple time zones.Full-TimeDirector

Salary not disclosed

Apply NowOpens the employer's application page

Job Details

Experience: 15+ years of relevant regulatory affairs or related industry experience; Master's degree with 12+ years, or PhD with 10+ years

Hold an advanced degree in molecular biology, genomics, or diagnostics; a PhD is preferred.
Have 15+ years of relevant regulatory affairs or related industry experience, or 12+ years with a Master's degree or 10+ years with a PhD.
Demonstrate success leading enterprise-level regulatory strategies and high-impact submissions.
Have experience with international diagnostics or medical device commercialization.
Have extensive experience interacting with senior-level global regulatory agencies and influencing international policy.
Know applicable medical device submission regulations, including IVDD, IVDR, FDA 21 CFR, and UK MDR 2002.
Know GMP quality management systems such as ISO 13485 and risk assessment frameworks such as ISO 14971.
Know clinical laboratory regulations, including CAP, CLIA, NYSDOH, and ISO 15189.
Understand protected health information regulations, including HIPAA and GDPR.
Understand regulated clinical study requirements, including ICH E6 (GCP), ISO 20916, and FDA 21 CFR Parts 11, 50, 54, and 56.
Bring global regulatory experience with US, EU, and international frameworks, submission pathways, and compliance requirements.
Demonstrate portfolio and enterprise decision-making capability, balancing regulatory risk, innovation, and business priorities.
Have advanced proficiency in enterprise regulatory systems, global submission platforms, and compliance tools.

Define and oversee global regulatory strategies for the product portfolio, aligned with business priorities and global requirements.
Drive Galleri commercialization across the EU, Asia/Pacific, the Middle East, and the UK.
Provide strategy and oversight for regulatory submissions, product approvals, and lifecycle management across geographies.
Partner with R&D, Quality, Clinical, Commercial, and Manufacturing teams and executive leadership to integrate regulatory considerations into enterprise strategy and portfolio governance.
Anticipate global regulatory and policy shifts, assess their impact, and shape company responses.
Prepare the organization for regulatory inspections, audits, and high-level interactions with authorities.
Influence international regulatory policy through industry forums, standards bodies, and regulatory working groups.
Lead the development, preparation, review, and execution of international regulatory submissions and product registrations.
Establish filing strategies, submission plans, timelines, dependencies, and governance for international commercialization.
Maintain regional registrations, regulatory records, commitments, and submissions, and ensure timely completion of post-approval and post-registration activities.

View Full Description & ApplyYou'll be redirected to the employer's site