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Regulatory Submissions Analyst
2 months ago
Job Title: Regulatory Affairs Specialist
Job Location: Fremont, CA
Job Duration: 12 months+ (Temp to perm)
Shift timing: Monday-Friday, 8 am - 5 pm
Pay rate: $36 - $39.50/hr on w2
Job Overview:
Position Summary:
As a Regulatory Affairs Specialist, you will play a pivotal role in facilitating the regulatory submission processes necessary for the implementation of IVDR related to Toxicology and Therapeutic Drug Monitoring Assays. Your responsibilities will include:
Key Responsibilities:
- Assist in the compilation and preparation of regulatory submissions for both European and global markets.
- Support the development of submission packages and dossiers for regulatory authorities, focusing on IVDR Technical Dossiers for CE Mark certification.
- Collaborate with regulatory colleagues from partner channels to secure product approvals.
- Organize, update, and manage regulatory documentation in compliance with departmental and organizational protocols, including maintaining comprehensive logs and trackers.
- Foster effective communication and collaboration with employees and partners at all organizational levels.
- Request and monitor the legalization of documents, apostille processes, and certificates from regulatory bodies.
- Manage change orders for documentation approval within the electronic records management system.
- Perform additional related duties as assigned, ensuring flexibility and responsiveness to organizational needs.
This role is essential for ensuring compliance and facilitating the regulatory processes that support our commitment to quality and safety in our products.
