Regulatory Affairs Director ISA
Core
Provides regulatory strategy and direction for healthcare product launch, premarket submissions, and postmarket 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
Required skills
Regulatory strategy, premarket submissions, postmarket compliance, team management, policy formulation, stakeholder negotiation, project management, industry trend analysis
Preferred skills
Trade association leadership, white paper creation, government department liaison
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; influence policy formulation and resource control; negotiate with external partners, vendors, or customers; work closely with regulators and government departments (e.g., AERB, CDSCO, BIS, MeitY, MoEFCC); shape compliant policies with trade associations.
Seniority
Director, strategic leadership & team management