Randstad Regulatory Affairs in San Jose, California
San Jose, CA Salary:
US$ 30 - US$ 40 per hour Date Posted:
Thursday, October 13, 2016 Experience:
3 years Job Type:
Regulatory Specialist needed for a 3 + month contract opportunity in the San Jose, CA area. Candidate would Analyzes customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Communicates event investigation results via regulatory reports and written communications, as appropriate.
Responsibilities for the Regulatory Affairs
Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
Evaluate and investigate identified complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
Draft written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers.
Collect, compile, and document regulatory reportability decisions using event investigation and regulatory decision models.
Requirements for the Regulatory Affairs
BS Degree with 0-5 years of related experience required.
Proficient with Microsoft Office.
Experience with drafting Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmition to the appropriate regulatory authorities.
General knowledge and application of technical and business concepts, procedures, and practices.
- Industry leading contractor benefits!
Job Number: 126071