Lafayette $75,000-$100,000 Contract
Promote cross-functional interactions to achieve quality outputs and to improve the CRMS
Provide vision, direction, development, and leadership to the Quality Assurance Team
Engage with Quality leadership to ensure development continues to be responsive to changing quality expectations
Formulates a justifiable stance on regulatory issues, articulating it with compelling reasoning and adapting the writing style to suit the intended audience.
Compiles documentation for submission to regulatory agencies.
Keeps meticulous records of technical documents dispatched to regulatory bodies.
Creates well-structured, comprehensive, and persuasive position papers or statements when necessary.
Drafts responses to inquiries or shortcomings raised by regulatory agencies.
Devises and executes regulatory strategies for both new and current products.
Acts as a company liaison to the FDA and foreign regulatory entities when necessary, both internally and externally.
BS in relevant field (MS preferred)
Minimum of 3 years professional experience is required
Maintains knowledge of requirements applicable to the performance of regulatory affairs and QA tasks.
Excellent oral, written, computer and interpersonal skills
Assures quality requirements are met Microsoft Office Suite and Project