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

smogtown13.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, smogtown13.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, smogtown13.com is the ideal place to find your next job.