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Regulatory Affairs Specialist
1 month ago
We are seeking an experienced Regulatory Engineer to support product regulatory compliance and submissions at Intellectt Inc. The ideal candidate will have expertise in 510(k) submissions, documentation, and technical writing to ensure products meet regulatory standards and are cleared for market entry.
Key Responsibilities:- Prepare and submit 510(k) filings and other regulatory submissions to relevant authorities.
- Develop, review, and maintain regulatory documentation to ensure compliance with FDA and global standards.
- Provide technical writing support for submission documents, regulatory reports, and SOPs.
- Collaborate with cross-functional teams to gather information required for regulatory filings.
- Monitor changes in regulatory standards and ensure product compliance.
- Support audits and regulatory inspections by providing appropriate documentation and reports.
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- 2-5 years of experience in regulatory engineering, preferably in the medical device or pharmaceutical industry.
- Strong knowledge of 510(k) submission processes and regulatory compliance.
- Excellent technical writing and documentation skills.
- Familiarity with FDA regulations and international standards is a plus.
