Regulatory Affairs Director ISA
Core
Provides regulatory strategy and direction for healthcare product launches, premarket submissions, and post-market compliance, working closely with global healthcare regulatory bodies.
Role type
Senior IC Regulatory Affairs Director
Builds
Regulatory strategies and compliance frameworks for medical technology products
Domain
Healthcare / Medical Technology / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory strategy, premarket submissions, post-market compliance, team management, policy influence, stakeholder negotiation, project management, industry trend analysis
Preferred skills
Thought leadership, trade association leadership, white paper creation, complex problem solving
Technologies
None stated
Responsibilities
Develop expertise and provide thought leadership within the function; manage a team of senior professionals; lead functional teams or projects with moderate complexity; negotiate with external partners, vendors, or customers; shape policies with regulators and government departments (e.g., AERB, CDSCO, BIS, MeitY, MoEFCC); create position papers on industry matters
Seniority
Director, strategy & mentorship