Sr. Associate, Regulatory Affairs Strategy
Core
Develop and execute regulatory strategies and plans for new and marketed medical device products to ensure timely submissions, approvals, and lifecycle compliance.
Role type
Senior Regulatory Affairs Strategy Associate
Builds
Regulatory dossiers, product licenses, and compliance documentation for health authority review
Domain
Medical devices / Regulatory Affairs
Required skills
Regulatory strategy planning, dossier preparation, license maintenance, regulatory record management, impact assessment, stakeholder engagement, labeling and promotional material review, market action support
Preferred skills
International environment experience, knowledge of ISO13485
Technologies
Veeva RIM
Responsibilities
Support development and execution of regulatory strategies and plans; Prepare and support submission of regulatory dossiers; Maintain product and establishment licenses; Monitor regulatory changes and conduct impact assessments; Engage with internal stakeholders and Health Authorities; Review local labeling and promotional materials; Provide support for market actions and health authority communications
Seniority
Senior, hands-on IC
