Regulatory Affairs Specialist
Proclinical is currently recruiting for a Regulatory Affairs Specialist for our client located in Jacksonville, FL. Successful candidate will coordinate, compile, and supply regulatory documents to regulatory teams in Latin America, Asia Pacific and Europe, Middle East and Africa for new product registrations, new product introductions, renewals and change submissions.
- Coordinate, compile, and supply regulatory documents to regulatory teams in Latin America, Asia Pacific and Europe, Middle East and Africa for new product registrations, new product introductions, renewals, change submissions, etc.
- Work with regulatory partners to ensure rapid and timely approval of new products and renewals.
- Researches, collects data, and addresses requests from regulatory agencies to prepare documentation required for health authority submissions
- Monitors the external environment to help ensure compliance with new regulations, requirements, etc.
- Work under minimal supervision, with benefit of previous regulatory experience.
- Requires a general use and application of Regulatory concepts, practices and techniques.
- Develop solutions to a variety of problems of moderate scope and complexity.
- Perform other duties as assigned by the manager of this position.
Skills and Requirements:
- Bachelor's Degree and a minimum of 2 years regulatory affairs work experience is required.
- Knowledge of European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC) is preferred.
- Experience with Quality Management System Standard ISO 13485 is preferred.
- Knowledge of International Medical Device requirements (China, Japan, Canada, Australia, Brazil, Russia, etc.) is preferred.
- Excellent written and oral communication skills are required.
- Good analytical thinking, organization, problem solving, and investigative skills are required.
- Proficiency in Microsoft Office and all related applications is required.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Calvin Lee at (+1) 312-291-4181 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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