We are seeking a highly skilled Regulatory Affairs Specialist to provide regulatory strategies for FDA submissions and support our growth in the medical device industry.
* Develop and implement regulatory plans to ensure compliance with FDA requirements.
* Provide strategic guidance on product development, labeling, and marketing materials.
* Collaborate with cross-functional teams to coordinate the preparation of FDA applications and responses.
Your Qualifications :
* Minimum 7 years of experience in regulatory affairs in the medical device industry.
* Proficient knowledge of quality standards (MDSAP / ISO 13485 / GUDID) and relevant FDA regulations.
* Demonstrated experience in communicating with regulatory agencies and leading PMA submissions for class III medical devices.
Prior experience with combination products and proficiency in French is a plus. The ideal candidate will be able to work on multiple projects simultaneously, prioritize tasks effectively, and possess strong written and oral communication skills.
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