RIGICON- REGULATORY AFFAIRS SPECIALIST
Rigicon is the global provider of prosthetic urology devices with headquarters located in New York. The job opening is for our Regional Office in Istanbul.
Qualifications:
- A./B.S., preferably within a technical or scientific related discipline, is required.
- Preferably 2 years of relevant / regulated industry experience or a Master’s degree with equivalent experience is required.
- Previous experience with EU Medical Device Regulation and Unique Device Identifier programs is preferred.
- Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.
- Experience in providing support to complex projects and making timely and effective decisions based on available information to execute project deliverables, especially in ambiguous or unclear situations.
Responsibilities:
As Regulatory Affairs Specialist, you will
- play a key role in providing regulatory guidance to project teams in strategic planning and related submissions.
- Working with minimal supervision independently, develop and execute regulatory strategy for country registrations to support continued commercialization of products in key countries.
- help to define data and information needed for regulatory actions in conjunction with cross-functional teams
- guide regulation conformance through the development of best practices for Regulatory Affairs processes, procedures and systems.
- Apply understanding and ensure compliance with regulatory agency/ Rigicon regulations and interpretations.
- Prepare responses to regulatory agencies’ questions and other correspondence.
- Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.
- Partner cross-functionally to develop solutions to a variety of problems with varying levels of scope and complexity
- Research and collect data, and respond to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals while providing routine regulatory information to associates and affiliates
- Advise on regulatory labeling requirements specifications for modified products, and review product labeling to ensure compliance
- Provide regulatory guidance to project teams and responds to product information requests Provide Regulatory Affairs support during internal and external audits Assist in the development of best practices for Regulatory Affairs processes Represent Regulatory Affairs on cross-functional project teams
