Parsippany, NJ
Principal Duties and Responsibilities
 Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions
 Assists in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions
 May provide regulatory direction to development project teams as a core team member; develops regulatory strategy for new products
 Reviews proposed labeling for compliance with applicable US and international regulations
 Writes package inserts
 Reviews and evaluates promotion and advertising material for compliance with applicable regulations
 Reviews proposed product changes for impact on regulatory status of the product 100 Total Percent (not to exceed 100%)*
Expected Areas of Competence (i.e. KSAs)
 Demonstrated strong writing and communication skills
 Strong attention to detail, ability to multi-task
 Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products
 Ability to function well as a member of the team and build relationships between RA and other areas of the organization
 Knowledge of FDA regulations (including labeling regulations) and regulations outside the US preferred
 Basic computer skills, including Microsoft Office Suite
Education/ Experience Requirements
 US Bachelor’s Degree in life sciences, technical (engineering) or related field (or non-US equivalent).
 No formal RA experience required, two years preferred
 Advanced experience in the areas that may include preparation of dossiers for product registrations outside the US; preparation of submissions to the FDA strongly preferred
 A combination of education and experience may be considered
Travel Requirements Up to 15%
Pay Rate: $23.02
Shift: 1st Duration: 1 Yr