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Regulatory Compliance Specialist
2 months ago
Job Title: Regulatory Affairs Specialist
Location: Fremont, CA
Duration: 12 months
Pay Rate: $35-40/hr
Position Overview:
As a Regulatory Affairs Specialist, you will play a crucial role in supporting the implementation of the In Vitro Diagnostic Regulation (IVDR) for Toxicology and Therapeutic Drug Monitoring Assays. Your responsibilities will include:
- Assisting in the preparation of regulatory submissions for both European and global markets.
- Organizing and reviewing materials necessary for regulatory submissions.
- Supporting the development of dossiers and submission packages aimed at obtaining regulatory approvals, including IVDR Technical Dossiers for CE Mark certification.
Key Responsibilities:
- Collaborating with regulatory colleagues to facilitate product approvals.
- Maintaining and updating regulatory documentation in line with company protocols, including logs and trackers.
- Fostering effective communication and collaboration across all organizational levels.
- Requesting and monitoring document legalization and certificates from regulatory bodies.
- Managing change orders for documentation within the electronic records management system.
- Performing additional duties as assigned.
Qualifications:
- A bachelor's degree, preferably in a scientific or engineering discipline.
- In-depth knowledge of EU IVD regulations.
- Exceptional verbal and written communication skills with a keen attention to detail.
- Ability to multitask, prioritize, and meet deadlines efficiently.
- Strong organizational skills with the capability to manage multiple projects simultaneously.
- Proficiency in Microsoft Office applications (Excel, Word, Outlook).
Work Environment:
This position requires full onsite presence at the Fremont, California facility, with a standard schedule of Monday to Friday, 8 AM to 5 PM.
About Dexian:
Dexian is a prominent provider of staffing, IT, and workforce solutions, boasting over 12,000 employees and 70 locations globally. Formed in 2023 through the merger of DISYS and Signature Consultants, Dexian is one of the largest IT staffing firms and the second-largest minority-owned staffing company in the U.S. Our platform connects talent, technology, and organizations to deliver transformative results that help individuals and businesses achieve their goals.
Dexian is an Equal Opportunity Employer, committed to recruiting and hiring qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
