Senior Regulatory Affairs Specialist

About the job

Job Description

Primary Function of Position The Sr. Regulatory Affairs Specialist’s primary responsibilities include developing regulatory plans, reviewing design input/output documentation, identification of applicable standards and guidance documents, performing regulatory assessments to determine the impact of design/process changes, preparing regulatory submissions, maintaining regulatory filings and licenses.

Essential Job Duties

• 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. • Author and lead regulatory documentation and submissions, including U.S. FDA 510(k) premarket notifications, internal Letters to File, , pre-submissions, Health Canada submissions with minimal supervision. • 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 submissions, approvals, and implementation rollouts.