Manager, Regulatory Affairs
Core
Develop and execute regulatory strategies for a portfolio of products to ensure compliance with global requirements and support business objectives throughout the product lifecycle.
Role type
Manager, Regulatory Affairs
Builds
Regulatory submissions, approvals, and compliance commitments for marketed product portfolios
Domain
Healthcare / Medical Devices
Required skills
Global regulatory strategy, risk assessment, stakeholder management, cross-functional leadership, regulatory submission processes, gap analysis, industry association representation, team coaching
Preferred skills
Multinational business environment experience, complex product development program support
Technologies
Regulatory submission systems, global compliance frameworks
Responsibilities
Develop and execute regulatory strategies aligned with business objectives; Lead regulatory activities for assigned product portfolios; Identify regulatory risks and implement mitigation strategies; Monitor global regulatory requirements and ensure compliance; Conduct regulatory gap assessments and implement process improvements; Serve as primary regulatory contact with health authorities; Lead, coach, and develop regulatory team members
Seniority
Manager, people leadership