Compliance Officer

Work with national and international regulatory requirements including USA (21 CFR), Europe (EU MDD / EU MDR), and Canada (CMDR). Perform EU MDD to EU MDR transition. Author regulatory submission for new medical device. Ensure regulatory compliance for new product by liaising with the R&D team. Created design & technical documentation for a new product. Apply design controls, and draft documentation for new product as per the FDA21 CFR 820.30, and EU MDR. Perform risk assessment and risk management in compliance to ISO 14971: 2019. Perform Gap Analysis and identify non-conformities with the current standards and regulations. Update the Device Master Record to comply with the 21 CFR Part 820 and EU MDR. Update documents and created risk management file in compliance with ISO 14971: 2019. Update and maintain the Quality Management System (QMS) by updating the existing or creating new Standard Operating Procedures (SOPs) and respective forms. Participate and assist with notified body audits, such as QMS compliance audit, CE technical files audit, Sterilization audit, ISO 13485 re-certification audit, MDSAP audit, and their follow up. Perform gap analysis and prepare required documentations for internal audits for QMS compliance, Design and Technical Files, Risk Management Files, Sterilization of products, and Post Market Surveillance to confirm compliance with FDA 21 CFR regulations and standards such as ISO 13485: 2016 and ISO 14971: 2019. Resolve and respond to resulting NCRs and/or CAPAs following an audit. Performed post market surveillance for all products. 2years’ Experience. Salary $80,600. Master’s Degree Required. Regular Full Time Employment. 40 hrs per week. Essential Dental Systems Inc. 89 Leuning Street, South Hackensack, NJ 07606. No Phone Calls, please send resume via USPS to Joel Burstein.

Salary/Compensation: $80,600 per year

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