Regulatory Affairs Specialist
Route 22 West Somerville, NJ 08876
A fortune 100 medical device company is currently looking for a Regulatory Affairs Specialist I.
This position supports strategic planning and product development efforts and provides Regulatory support for existing products with respect to product changes/modifications.
POSITION DUTIES & RESPONSIBILITIES:
- Ensures compliance with regulatory agency regulations and interpretations.
- Prepares responses to regulatory agencies' questions and other correspondence.
- Assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Provides solutions to a variety of problems of moderate scope of complexity.
- Conducts searches of existing files for requested information.
- Maintains and archives all regulatory documentation.
Functional and Technical Competencies:
- Leverages a working knowledge of the regulatory environment, including compliance, current and proposed laws, regulations and guidance, to prepare compliant Regulatory strategies that are aligned with the business objectives of the company, including consideration of the global regulatory environment.
- Executes Regulatory strategies in compliance with relevant laws, regulations, and organizational requirements necessary to obtain, and maintain, legal market status.
- Leverages scientific and technical understanding of products under scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products
- Effectively manages multiple competing priorities of different functional partners based on factors such as required regulatory submission due dates, time constraints, urgency, and business need
- Develops written technical communications that are clear and tailored to the audience and business need (for example, responses to regulators, submission dossiers).
- Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.
- Minimum of a B.A. /B.S. within a technical related discipline is preferred.
- Minimum of 1 year of experience in Regulatory Affairs or a Master’ s degree with equivalent experience.
- Ability to work both independently and in a team environment. Ability to problem solve, recognize and find solutions for gaps in processes.
- Preferred 510(k) submission and CE-marked Design Dossier and Technical File management experience
- International regulatory experience desired