Principal Compliance Engineer - Medical/Healthcare
Posted on Dec 13, 2018 by Affinity Executive Search
* 21 CFR 820
* 21 CFR 4
* ISO 13485/EN 1SO 13485
* ISO 14971/EN ISO 14971
* European Medical Devices Directive
* Canadian Medical Devices Regulations SOR/98-282
* ANVISA (National Health Surveillance Agency Brazil)
* Good Manufacturing Practices (GMPs) of Medicinal Products
* Any other applicable regulations or standards.
* Support the external inspection and audit management of the site.
* Implement proactive compliance initiatives.
* Provide compliance guidance to the site, including compliance support for Quality improvements and remediation activities.
* Serve on cross-site and cross-segment project teams consistent with company goals and objectives to improve overall compliance performance to established metrics and requirements.
* Support in the management of internal and external audit observations to ensure identified gaps or systemic risks are identified and closed in a robust and timely manner.
A long-termglobal technology and research-based manufacturing leader in the medical/healthcare products area has an immediate need for a Principal Compliance Engineer at one of their key operational sites located in the Gainesville, GA, region northeast of Atlanta. This "blue chip" company provides cutting edge research, development, and manufacturingfor some of todays most well-known and successful medical and surgical products. They provide very competitive compensation and outstanding benefit packages to go along with seriouscareer development and growth opportunities here in the US and all over the globe.
* A minimum of a Bachelors degree or equivalent is required, preferably in Engineering or a related technical field.
* A minimum of 8 years of experience in a Food and Drug Administration (FDA) regulated industry (i.e. Pharmaceutical or Medical Devices) or another highly regulated industry is required.
* Knowledge of ISO 13485 and 21 CFR 820 is required.
* Experience leading internal Quality System audits is required.
* The ability to travel to 15% (mostly regionally) is required.
* Experience in Compliance, Quality, Manufacturing or Engineering roles preferred.
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