Regulatory Affairs Specialist
4 weeks ago
Job Summary:
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at IntelliPro Group Inc. This role will be responsible for ensuring compliance with regulatory standards for medical devices, including Class I, II, and III devices.
Key Responsibilities:
- Collaborate with cross-functional teams to conduct regulatory pre- and post-market analyses.
- Prepare and review regulatory submissions to the US FDA, including 510(k) and EUA applications.
- Support government interactions pertaining to medical device registrations and licensing.
- Develop and implement regional regulatory strategies.
- Provide regulatory support to product development and project teams throughout the product lifecycle.
Requirements:
- Bachelor's degree in Science, Engineering, Math, or a medical field.
- Minimum 5 years of experience in medical device Regulatory Affairs.
- Strong analytical and communication skills.
- Ability to manage small projects and work independently.
About Us:
IntelliPro Group Inc. is a global leader in talent acquisition and HR solutions. We are committed to delivering unparalleled service to clients, fostering employee growth, and building enduring partnerships.
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