Our Client, an American Biotechnology company, is looking for a Regulatory Affairs Specialist 4 for their Sunnyvale, CA/Hybrid location. Responsibilities:

+ Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.

+ Determine regulatory pathways and formulate regulatory strategies for the U.S. and Canadian markets.

+ Assess regulatory impact on design, materials, labeling, packaging, manufacturing processes, and facility changes. Influence and lead global regulatory strategies.

+ Coordinate with technical experts to provide additional data/information requested by regulatory agencies and prepare responses to facilitate regulatory approvals.

+ Provide risk-based guidance and regulatory input to projects and issues, ensuring cross- functional alignment and resolution.

+ Collaborate with international counterparts to support global regulatory submiss...