Job Description

Responsibilities:

• Represent and/or lead Regulatory Affairs in project teams throughout product life cycle.
• Write/review protocols for analytical studies in support of regulatory submissions.
• Assist in the preparation and submission of EUAs, pre-submissions, 510(k)s for class II products.
• Support international registrations, create and maintain technical files, and prepare product dossiers.
• Prepare and maintain Design History Files.
• Lead Risk Management effort.
• Prepare and review labeling and marketing materials to ensure regulatory compliance.
• Help set the regulatory strategy for new product development.
• Keep abreast with the latest regulatory requirements and trends.
• Communicate with the FDA and other regulatory bodies concerning product submissions.

Requirements:

• PhD and 1yr of industry experience, MS + 1yrs or BS + min. 3yrs of experience with FDA-regulated IVD manufacturing company.
• Prior experience in regulatory submissions (pre-submissions, EUA, 510(k), De Novo, PMA) for lateral flow and real-time PCR assays.
• Excellent knowledge of US and international IVD regulations.
• Strong written and verbal communication skills.
• Ability to manage multiple projects and deadlines.
• Strong understanding of statistical analysis.
• Ability to identify compliance risks and escalate when necessary.
• Technical system skills (e.g., MS Office, SharePoint, statistical packages, online research).

Job Types: Full-time, Contract

Schedule:

• Day shift
• Monday to Friday

Ability to commute/relocate:

• Dallas, TX: Reliably commute or planning to relocate before starting work (Required)

Experience:

• FDA regulations: 1 year (Preferred)

Work Location: In person

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