Regulatory Affairs Associate
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Job Summary
Seeking a skilled Regulatory Affairs Associate, this remote contract position will manage and optimize the preparation, publishing, and electronic submission of regulatory documents for global diagnostic products, ensuring compliance with U.S. and EU regulations.
Key Responsibilities
- Lead the preparation and electronic submission of regulatory dossiers, ensuring compliance with various submission types such as 510(k), PMA, and IVDR
- Utilize platforms like Veeva Vault and eCTD Xpress to compile and validate regulatory submission packages
- Oversee submission lifecycle management and collaborate with cross-functional teams to troubleshoot publishing challenges
Required Qualifications
- Bachelor's degree in Life Sciences, Regulatory Science, Quality Assurance, or a related field; advanced degree preferred
- 5+ years of experience in regulatory submission publishing within diagnostics or related life sciences industries
- Familiarity with AI, RPA, or regulatory publishing automation tools is highly preferred
- Strong understanding of FDA, EMA, and ICH regulatory standards
- Experience in continuous improvement and process automation
Complete Job Description
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