Randstad Regulatory Affairs in San Jose, California
location:San Jose, CA
salary:$34.57 - $36.65 per hour
date posted:Tuesday, February 5, 2019
industry:Miscellaneous Manufacturing Industries
Contract position: A Regulatory Affairs Analyst is needed for a manufacturer of optics products in the San Jose, CA area. This position will review and perform RA investigation for medical device complaints, and determine the resolution of the complaint. No per diem available. No travel anticipated.
Responsibilities for the Regulatory Affairs
Determine if a reported event classifies as a Medical Device Reportable as defined by various regulatory agency. File proper documentation with applicable agencies as needed.
Coordinate MDR investigations with Infection Control staff. Monitor and track progress of any outside laboratory evaluation, when necessary.
Maintain traceability, and manually and electronically document the applicable elements of the complaint handling process.
Requirements for the Regulatory Affairs
Bachelor's degree is preferred, high school diploma or GED are required. At least 1 year of complaint handling in a field closely related to medical devices or the pharmaceutical industry.
Understanding and compliance with applicable FDA regulations and MSG operating procedures, processes, policies and rules are essential.
Knowledge in medical terminology and human anatomy are desired. Knowledge in Quality System Requirements (21 CFR 820 & 803) is required.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.