Regulatory Affairs Professional
3 weeks ago
At IntelliPro Group Inc., we are seeking a highly skilled Regulatory Affairs Professional to join our team. This role will be responsible for overseeing the regulatory aspects of medical device development and market introduction.
Key Responsibilities:
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
- Develop and maintain an ISO 13485 and FDA-compliant Quality Management System.
- Prepare and review regulatory submissions to the US FDA and international regulatory authorities.
- Support government interactions related to medical device registrations and licensing.
- Contribute to the development of regional regulatory strategies and update strategies based on regulatory changes.
About the Role:
- Bachelor's degree in Science, Engineering, Math, or a medical field.
- Minimum 5 years of experience in medical device Regulatory Affairs.
- Demonstrated ability to manage small projects and display exceptional organization skills.
Estimated Salary: $120,000 - $200,000 per annum.
Benefits:
- Comprehensive benefits package.
- Ongoing training and professional development opportunities.
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