Director of Quality/Regulatory Affairs, North America

Founded in 1987, HoMedics is a leader in consumer health, wellness, home environment, consumer electronics, and lifestyle products. Our family of brands includes HoMedics, the #1 brand in massage; HMDX Audio and JAM Audio, makers of the top-selling Bluetooth? speaker in America; and The House of Marley, a high-performance audio brand developed in partnership with the Bob Marley family. We distribute our products to more than 60 countries throughout North and South America, Central America, the Asia-Pacific region, and Europe, Africa, and the Middle East.
We are seeking a Director of Quality/Regulatory Affairs, North America who will be responsible for directing all aspects of product quality and regulatory compliance for consumer products sold in North America, including class I and class II medical devices. The ideal candidate will be well versed in FDA regulations to ensure continuous product compliance.
Essential Functions:
Lead a team of quality and regulatory staff to ensure all North American governmental, industry, and international reporting systems and documentation comply with regulatory requirements for medical devices and consumer products.
Ensure systems are established to determine regulatory risk of suppliers and for taking corrective action as needed.
Establish strategic plan for the Quality/Regulatory Department based on company goals and strategy.
Develop and administer quality programs including training and coaching employees.
Collaborate with the Engineering and Product Development teams to produce quality products.
Monitor and ensure compliance to FDA Quality System Regulation, Canadian medical device regulations, EPA and other agency standards.
Direct the accumulation, assimilation, analysis, communication/distribution of all quality and regulatory data, and provide documented metrics and trend data tools for managing information, performing root cause analysis, and closed loop corrective actions.
Maintain a monitoring and trending program to ensure general state of compliance is effective and continuously improving.
Act as primary liaison with regulatory authorities related to quality and compliance policies, guidelines, systems, and audits.
Act on behalf of the company for quality and regulatory issues within the organization. Must be able to speak in a public forum in front of government officials and/or clinical professionals.
Manage the QA/RA department budgets as well as primary input to product development budgets related to quality and regulatory and safety agency issues.

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