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Responsibilities:
- Involve in Innovation projects - Advice project team on regulatory aspects and changes that would affect product manufactured.
- Prepare Product Technical File.
- Involve in product registration - Prepare product registration documents for the requested countries, work with regulatory body/agency on required document for registration submission.
- To apply for Free Sale Certificate & Manufacturing Certificate and arrange for legalization of certificates.
- Work with HQ on Regulatory documents and Release order.
- Support marketing on label changes and marketing material review.
- Other regulatory task as assigned.
Requirements:
- Degree in Science or Engineering.
- Preferable with minimum 3 years' working experience in Regulatory Affairs.
- Knowledge of ISO13485.
- Knowledge of regulatory and registration document submission in Rest of World.
- Personal - Committed with positive attitude, flexible, good accountability and good team spirit.
What can Ambu offer you?
Ambu is experiencing a very positive and exciting development. We are a dynamic and international workplace with skilled colleagues who emphasize freedom with responsibility and to have a good working environment.
Ambu’s ambitious growth objectives means that there is a natural focus on the ongoing development of your professional and personal skills that will help to ensure our continued success.
We offer a wide range of professional, social and economic benefits, in addition to the exciting challenges of the job, which adds to your job satisfaction.
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