Regulatory Affairs Specialist

We’re looking for a skilled Regulatory Affairs Specialist to manage and coordinate regulatory submissions for medical devices. If you have experience with FDA, CE submissions, and medical device regulations, we want to hear from you!

Responsibilities:

• Manage regulatory strategy and submissions (ISO, FDA, CE, 510(k), etc.).
• Assist R&D and Marketing teams with regulatory aspects.
• Ensure proper maintenance of product registration files.
• Communicate with regulatory agencies and stay updated on emerging regulations.

Requirements:

• BA/MA in Science fields.
• 1-2 years of experience in regulatory affairs for medical devices.
• Experience with FDA and CE submissions.
• Knowledge of relevant standards for medical equipment.
• Fluent in English, with excellent communication skills.