Regulatory Affairs Associate
GForce Life Sciences, Santa Clara, CA, United States
Hands‑on experience with regulatory labeling, including addendum labeling, supplemental labeling, and/or execution of labeling changes
Familiarity with regulated medical device environments and quality systems
Filing necessary applications and handling government interactions related to regulatory processes for products requiring approval
Authoring and submitting PMA supplements (30‑day Notice, Real‑Time Reviews, 180‑Day Supplements, Annual Reports)
Review and approval of engineering study protocols/reports and validation study protocols/reports
Review and approval of manufacturing changes for Class III implantable medical devices
Planning and accomplishing goals using experience and judgment
Performing a variety of tasks and potentially leading or directing the work of others
Qualifications
5+ years of experience in Regulatory Affairs Recent experience with Class III implantable medical devices Proven track record of authoring, submitting, and obtaining approval for Class III implantable PMA supplements Knowledge of FDA PMA guidance documents and CFR regulations Ability to work with a wide degree of creativity and latitude Typically reports to a manager or head of a unit/department
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5+ years of experience in Regulatory Affairs Recent experience with Class III implantable medical devices Proven track record of authoring, submitting, and obtaining approval for Class III implantable PMA supplements Knowledge of FDA PMA guidance documents and CFR regulations Ability to work with a wide degree of creativity and latitude Typically reports to a manager or head of a unit/department
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