20564– Quality & Regulatory Manager (QARA)

The Quality and Regulatory Manager is responsible for the daily management of all aspects of the quality and regulatory function. The QARA Manager will ensure the implementation, proper execution, and maintenance of the quality system in accordance with FDA’s Quality Management System Regulation (QMSR), ISO 13485:2016, and other relevant industry standards. This individual will manage the Quality and Regulatory teams, to ensure the continuing suitability and effectiveness of the Quality Management System.

Job Duties:

• Responsible for the Quality Management System, including CAPA, internal and external audits, management review, complaints and adverse events, employee quality training, supplier management, and remedial action.
• Ensures implementation, effectiveness and integrity of quality management system that is compliant to all applicable standards and regulations.
• Approval rights for Quality Agreements and other contracts requiring Quality and Regulatory review.
• Leads all third-party Quality System inspections, including customers, FDA, notified bodies and all other regulatory bodies.
• Assumes responsibilities of the Management Representative and as such chairs Management Review meetings.
• Ensures quality metrics and key process indicators are identified, measured and action driven.
• Identifies unacceptable trends and applies suitable corrective action in order to meet strategic objectives.
• Facilitates the CAPA process, assigns CAPA investigations, reviews CAPA plans, implementations, and surveillance results.
• Support R&D and Marketing in the development of new or improved products.
• Responsible for Site Quality Control, including incoming/in-process/final inspection, nonconforming material, and calibration system.
• Process owner for Product and Facility registration, including 510(k), UDI and GUDID Submissions
• Lead Correspondent for all matters concerning a Regulatory Authority.
• Other duties as assigned.

Skills/Qualifications:

• Must have extensive knowledge and understanding of FDA Title 21 CFR Part 820, 801, 803, 806, 807, 830 and ISO 13485.
• Experience with FDA 510(k) and GUDID Submissions.
• Knowledge of Medical Device and Pharmaceutical traceability requirements pertaining to specific State Distribution laws and licensing requirements.
• Experience with Complaint handling and Adverse Event reportability.
• Familiarity with MasterControl eQMS preferred.
• Excellent computer proficiency (MS Office Word and Excel, Microsoft 365, TEAMS)
• Excellent English verbal and written communication skills, including ability to effectively communicate with internal and external customers.
• Must have strong interpersonal and leadership skills to motivate team members and collaborate with various departments and personalities among various cultural settings.
• Excellent attention to detail and demonstrated ability to prioritize, organize, and work effectively with minimal supervision.
• Due to the high paced time sensitive environment, the incumbent is required to have a strong sense of urgency with the ability to prioritize workload according to identified demands.
• 5+ years of experience as a Manager or Leader of a Quality team in the Medical Device arena.
• 5 yrs. medical device industry experience.
• 5 yrs. of Quality Engineering/auditing experience.
• Bachelor’s degree preferred; however other candidates may be considered with relevant work experience.
• Safety sensitive position