What are the responsibilities and job description for the Regulatory Affairs Associate position at Intellectt Inc?
Role: Regulatory Affairs Associate
Location: Abbott Park, IL 60064
Key Responsibilities:
- Assist in the preparation, review, and submission of regulatory documents for new and existing medical devices.
- Support the regulatory team in ensuring compliance with U.S. FDA regulations, EU MDR, and other international regulatory standards.
- Monitor and track the regulatory submission process, including timelines, document preparation, and regulatory filing.
- Communicate with internal teams, such as R&D, Quality, and Manufacturing, to ensure regulatory requirements are met for device development and manufacturing.
- Assist in regulatory assessments of product changes, including labeling, packaging, and design modifications.
- Ensure that all necessary regulatory approvals and certifications are in place for products.
- Maintain and update regulatory files and documentation as required.
- Prepare responses to regulatory inquiries from health authorities.
- Support the regulatory team in conducting regulatory intelligence activities to stay current with evolving regulatory requirements.
Required Qualifications:
- Education: Bachelor’s degree in Life Sciences, Engineering, or a related field.
- Experience: At least 2 years of experience in regulatory affairs, with a focus on medical devices.
- Knowledge: Familiarity with FDA 21 CFR Part 820, ISO 13485, and other relevant regulatory standards and guidelines for medical devices.
