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Regulatory Affairs Specialist

3 months ago

Fremont, 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 Description:

Summary:

· Assist in the preparation of regulatory submissions in support of IVDR implementation of Toxicology and Therapeutic Drug Monitoring Assays. Tasks include:

· Organize and assist in the review of materials for inclusion in regulatory submissions both in the EU and worldwide.

· Support the preparation of dossiers and submission packages for regulatory agencies, including IVDR Technical Dossiers for CE Mark approval.

· Coordination with partner channel regulatory colleagues to obtain product approvals.

· Organize, update, and maintain regulatory documentation in accordance with department and company procedures including maintaining logs and trackers.

· Maintain positive and cooperative communications and collaboration with all levels of employees and partners.

· Request and track document legalization, apostille, and requests for certificates from regulatory agencies.

· Process changes orders for approval of documentation in the electronic records management system
Perform other related duties and responsibilities, on occasion, as assigned.