This is a part time consultant position. Hours will vary depending on project. This role is responsible for providing regulatory direction and strategy for FDA combination product human factors submission in accordance with applicable regulatory requirements. They will be responsible for reviewing and managing the submission of these regulatory submissions. They also will serve as a liaison between regulatory and other functional areas including external partners, clients and consultants in the planning, organizing, and preparing of regulatory documents for submission.
ESSENTIAL DUTIES AND RESPONSIBLITIES:
Responsible for developing and implementing regulatory strategy for projects, as assigned.
Provides advice and support to project teams for regulatory operations aspects of projects ensuring adherence and compliance.
Actively drives interactions with regulatory bodies, as assigned.
Assesses regulatory files to determine conformance to applicable regulatory requirements. Provides guidance to project teams on addressing any compliance issues or risks.
Assist in the preparation, coordination, management of simple and complex human factors regulatory submissions for combination product in the US in accordance with applicable regulations.
Translates regulatory requirements into practical, workable requirements; assist in the coordination internal/external authoring/review/comment adjudication and finalization of submission related documents.
Provides regulatory expertise in comments during document review, mindful of regulatory requirements pertaining to document content.
Interfaces with internal and external functional groups in the preparation, review, compilation, finalization submission and posting of regulatory submissions.
Acts as liaison between regulatory and other functional areas; represents regulatory in cross-functional team meetings.
EDUCATION, SKILLS AND EXPERIENCE REQUIRED:
BA/BS degree in health or science related discipline. Experience in FDA combination product human factors submissions. Experience in regulations and standards applicable to the United States.
Demonstrated experience as a self-starter and a fast learner; must work efficiently, both independently and within a team; must have very good problem-solving skills and attention to details. Excellent written and verbal communication skills are required and must be able to write clear reports, papers, proposals, etc., and efficiently discuss the same with other scientists, engineers, and customers. Must be proficient in project management; be extremely flexible and able to work in a fast-paced environment. Must also be able to interact with a diverse group of colleagues both internally and externally in a professional and collaborative manner. Independent judgment is required to plan, prioritize, and organize diversified workload.