QA Specialist

Job Responsibilities:

• 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.

Qualifications:

• 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