Sr. Regulatory Affairs Specialist

Actalent

📍 Westlake Village, CA, United States

Full-time other-general

Job Description

Description

Position Summary We are seeking an experienced Regulatory Affairs professional to support global regulatory compliance and product lifecycle activities for a portfolio of medical devices. This individual will partner with cross-functional teams to develop regulatory strategies, prepare submissions, maintain product registrations, and ensure ongoing compliance with applicable international regulations. This role requires strong technical writing skills, regulatory knowledge, and the ability to manage multiple projects within a dynamic product development environment. Key Responsibilities Develop and execute regulatory strategies supporting new product introductions, product modifications, and ongoing regulatory maintenance activities. Prepare, review, and submit regulatory documentation to support product approvals, registrations, renewals, and market access activities in domestic and international markets. Maintain global product registrations and regulatory license...
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