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Regulatory Compliance Specialist

2 months ago

Fremont, California, United States Careerbuilder-US Full time

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 crucial role in supporting the implementation of IVDR for Toxicology and Therapeutic Drug Monitoring Assays. Your responsibilities will include:

  • Assisting in the development of regulatory submissions for both European and global markets.
  • Collaborating in the preparation of comprehensive dossiers and submission packages aimed at securing approvals from regulatory bodies, including IVDR Technical Dossiers for CE Mark certification.
  • Coordinating with regulatory colleagues across partner channels to facilitate product approvals.
  • Maintaining and organizing regulatory documentation in compliance with departmental and organizational protocols, including the upkeep of logs and trackers.
  • Fostering effective communication and collaboration with colleagues and partners at all organizational levels.
  • Managing requests for document legalization, apostille, and certificates from regulatory authorities.
  • Processing change orders for documentation approval within the electronic records management system.

Additionally, you may be assigned other related tasks as necessary to support the team and organizational goals.