Job description
RESPONSIBILITIES:
- Ensures compliance with regulatory agency regulations and guidance.
- Execute strategies associated with product changes, including collaborating with business partners, communication with affiliates, providing registration support and ensuring implementation of the change.
- Supports and responds to regulatory requests from global affiliates and regulatory agencies.
- Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
- Maintains EU Technical Documentation for the medical device.
- Prepares responses to regulatory agencies' questions and other correspondence.
- Support labeling reviews by ensuring compliance to labeling requirements and regulations.
- Provides regulatory guidance to cross-functional project teams.
- Provide Regulatory Affairs support during internal and external audits.
- Leverages scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products (for example, provides Regulatory input into product recall strategies).
- Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.
- Consult with others to understand the benefits, risks, and Credo-based impact associated with decision alternatives before making decisions.
- Provides support to projects and makes timely and effective decisions based on available information to execute project deliverables.
- A minimum of a B.A./B.S., preferably within a technical or scientific related discipline, is preferred.
- A minimum of 2-4 years of relevant / regulated industry experience is required.
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