Position Title
Sr. Regulatory Affairs Specialist, AsLA
SBU
Medical
Department
Regulatory Affairs
Relocation Covered
YES
Educational Requirements
Bachelor's degree
Experience Requirements
Coordinates and prepares moderately complex regulatory submissions, including 510(k) premarket notifications, EU MDD Technical Files, and/or other documentation required for worldwide registration/licensure of products outside the U.S. Interfaces as needed with FDA, Notified Bodies or other national health agency regarding new products and significant changes to products. Provides a regulatory expertise and oversight to design teams. Serves as RA team member for promotional materials review, experimental designs, data analysis, risk management and product labeling as they relate to registration and commercialization of medical devices. Insures compliance with design controls and reviews design documentation to insure regulatory requirements are met. Reviews product development to assure collection of appropriate data for regulatory submissions and regulatory compliance. This includes use of appropriate standards, experimental designs, evaluation criteria, and statistical rationale. Participates in business interactions and negotiations with regulatory agencies on premarket submission requirements, formats, labeling claims, etc. Monitors FDA and other government agency laws and regulations through websites and publications. Prepares monthly reports to Director of RA. Provides support to more senior RA staff, and performing other related duties and assignments as required. Brings Regulatory Affairs questions/issues to the attention of RA management. Coordinates/directs regulatory projects. Directs/ guides junior regulatory Specialists.
Qualification Requirements
Bachelor's degree in a scientific discipline and a minimum of 3-5 years experience working in international medical device Regulatory Affairs.
Preferred Qualifications
The ideal candidate would have a degree in a scientific discipline such as biology, microbiology, chemistry, engineering, or medical technology. Individuals who have obtained a Regulatory Certification are a plus.
Responsibilities
Working Knowledge of FDA and international regulatory requirements. Orientation for detail with product, with emphasis on accuracy and completeness. Effective written and oral communication skills. Good organizational and planning skills; drives for results. Effective analytical/problem solving skills and good interpersonal skills that include working well in a team environment and the ability to lead others. Ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices. Ability to handle multiple tasks and to prioritize/ schedule work to meet business needs with routine supervision. Working knowledge of design control Ability to identify areas of concern in moderately complex projects and manage change.
