Akkodis is Seeking a Regulatory Affairs Associate for location of Santa Clara, California. This is a 12-month contract Position. Ideally looking for a candidate with experience in medical device Manufacturing Industry
Pay Range: $38 - $43/hour; The rate may be negotiable based on experience, education, geographic location, and other factors
5+ years of experience in Regulatory Affairs
Hands-on experience with regulatory labeling, specifically addendum labeling, supplemental labeling, and/or execution of labeling changes. Demonstrated familiarity with regulated medical device environments and quality systems. Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing changes for Class III implantable medical devices. Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. May lead and direct the work of others. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.
If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, please contact Ayush Kumar at 610 735 6638 or ***email_hidden***
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.
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