International Regulatory Affairs Specialist - United States
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- 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 or BA degree in a technical or scientific discipline or 5 years of cumulative work experienced in a Quality Assurance or Regulatory Affairs or other closely related field.
- Prefer 3 to 5 years' related experience plus Bachelor's degree.
- Concentration in clinical diagnostics preferred. International registration experience 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.