The International RA Specialist is responsible for developing strategies for moderately complex submissions to regulatory agencies worldwide. Interprets regulations and guidance’s ex-U.S. and communicates to the country how these impact the ability to register. Coordinates and supports worldwide product registration requests, interfaces with global international regulatory and marketing contacts to support regional registration requirements, and develops and maintains department procedures for international product registrations. Assembles technical information, in order to fill the registration requirements. In addition, the Specialist is responsible for understanding the needs of the regions and how to meet their registration needs as well as the objectives of the business.
- Coordinates timely preparation of requests for Certificates to Foreign Government, Certificates of Manufacture and Free Sale and Certificates of Exportability.
- Interfaces with applicable regulatory agencies and international consulates.
- Coordinates and collects specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments, as necessary to support registration requirements.
- Interfaces with OEM's to collect specific registration information.
- Assembles technical information to create a "clinical report" or a "dossier".
- Acts as lead for key countries, as identified, managing each request to completion.
- Recognizes and proposes continuous process improvements.
- Assists in the preparation of Technical Files for CE marking, checklists for Australia and for Singapore.
- Develops and maintains departmental procedures (SOP's and work instructions) for international product registrations.
- BS degree in a technical or scientific discipline
- 2-3 years' of international regulatory affairs experience in IVD preferred
- Concentration in clinical diagnostics preferred. International registration experience preferred.
- Knowledge of Asia Pacific- China regulations preferred.
- Demonstrates good technical/scientific skills on multiple product lines.
- Knowledge of both US and worldwide registration and regulatory requirements.
- Ability to effectively communicate both verbally and in writing to all levels internally and externally.
- Proficient in Microsoft Office Suite; with exceptional skills in constructing, populating and maintaining databases and spreadsheets.
- Strong communication and project management skills.
- Must be able to handle multiple tasks, prioritize and pay close attention to details.
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