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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