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Quest Diagnostics · 1 day ago

Senior Specialist, Regulatory Affairs

San Juan Capistrano, CA

Full-time

Onsite

Mid, Senior Level

$90K/yr - $130K/yr

5+ years exp

Quest Diagnostics is a leading provider of diagnostic information services, and they are seeking a Senior Specialist in Regulatory Affairs. This role involves creating, evaluating, and executing domestic and international regulatory tasks to drive market growth and ensure compliance with health authorities.

BiotechnologyHealth CareHealth DiagnosticsInformation ServicesPrecision Medicine

No H1B

Responsibilities

Plans and prepares regulatory submissions (510(k), PMA, Technical Files and other regulatory documentation) for product approvals/clearances required by the US FDA and international government agencies, including requisite pre-submissions and post-market approval reports with moderate supervision. Ensures regulatory submissions are prepared and processed in a proactive and timely manner

Evaluates proposed changes for regulatory impact with minimal supervision

Responsible for regulatory review of protocols, reports and data for conformance with the requirements and expectations of health authorities

Responsible for regulatory review of labeling, advertising and promotional materials

Maintain knowledge base of existing and emerging regulations, standards, or guidance documents and provide interpretive assistance to cross-functional teams

Compile and review regulatory submissions for completeness and quality. Ensure that submissions are in conformance with the latest industry and health authority submission standards

Assist with logging, tracking and filing correspondence and submissions to/from regulatory authorities and ensure that no commitment remains unduly outstanding

Identify and draft necessary SOPs and/or Working Practices for Regulatory Affairs