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The specialist will prepare and review IND/IDE applications, safety reports, and protocol amendments while managing regulatory correspondence. They will also maintain regulatory files and support FDA meetings and interactions for clinical research programs.
Saratoga Medical is hiring a Remote, Senior IND/IDE Regulatory Affairs Specialist. Package includes competitive rate and benefit options. Please see qualifications below and submit your resume if you are interested in being considered:
Education: Bachelor's degree in a scientific or related field required; advanced degree or RAC certification preferred.
Experience: Minimum of 7 years of regulatory affairs experience, including at least 5 years supporting FDA IND and/or IDE submissions.
Qualifications:
Saratoga Medical Center, Inc. is an equal opportunity employer and will not discriminate in recruiting, hiring, training, promotion, transfer, discharge, compensation or any other term or condition of employment on the basis of race, religion, color, age (over age 39), sex, national origin, or on the basis of disability if the employee can perform the essential functions of the job, with a reasonable accommodation if necessary.
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