Manager, Regulatory Affairs & Quality Assurance - Sonendo, Inc.

Sonendo, Inc. is a medical technology company with a unique mission to lead the transformation of dentistry through Sound Science®. We are currently building a high-performance team with a passion for creativity and innovation that is committed to collaboration and integrity. We believe our success is based on developing disruptive technologies, and we strive to achieve excellence in our products and services by attracting energetic, entrepreneurial individuals who are committed to this vision.

We are seeking an experienced Manager of Regulatory Affairs and Quality Assurance to oversee and maintain Sonendo’s Quality Management System and ensure regulatory compliance. This role requires hands-on experience with US and Canadian markets and a thorough understanding of ISO 13485, 21 CFR 820 and SOR/98-282. The RA/QA Manager will lead quality and compliance initiatives, manage risk, and oversee various regulatory and quality assurance activities to ensure our products meet all regulatory requirements.

• Colloborate with R&D, manufacturing and Marketing teams to provide regulatory guidance and ensure regulatory compliance throughout the product lifecycle.
• Manage the registration of products in international markets, including understanding and addressing unique regulatory landscapes.
• Lead and manage the Quality Management System, ensuring adherence to relevant standards and regulations.
• Participate in Risk Management activities, providing technical expertise on identifying and mitigating design and use risks.
• Support the execution of product registrations, including US FDA submission (510(k) and other international filings and registrations.
• Prepare and submit regulatory filings to relevant authorities.
• Evaluate proposed design changes and Engineering Change Orders (ECOs) for regulatory impact.
• Review product labeling and marketing materials to ensure regulatory compliance.
• Oversee internal and external audits, address observations, manage responses and ensure necessary certifications are maintained.
• Manage vigilance activities and complaint-handling related processes, including FDA adverse event reporting and post market surveillance.
• Monitor, approve, and manage potential adverse events ensuring timely and accurate reporting.
• Direct Corrective and Preventive Action (CAPA) activities, including root cause analysis and failure investigations, product dispositions, risk assessments, report preparation.
• Maintain compliance with company policies and procedures and perform other quality and regulatory duties as assigned.
• Lead efforts to collect data to determine the need for Field Corrective Actions.

• A Bachelor of Science degree in engineering (or equivalent technical discipline) is required. RAC certification is a plus.
• At least eight (8+) years of work experience in a regulated industry (medical device preferred)
• At least three (3+) years of experience managing or supervising a team in a Quality and Regulatory role.
• Excellent verbal communication skills, including ability to effectively communicate with internal and external customers
• Excellent computer proficiency (MS Office – Word, Excel, and Outlook)
• Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary customer service
• In-depth knowledge of US and international regulations (FDA, ISO, MDSAP, etc.) in Class II/Class IIb medical devices

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Position is primarily sedentary and employee may be required to sit for extended periods of time.  Standing, walking and meeting activities are required frequently throughout the workday.  Employee must be able to process paperwork and utilize office equipment (including personal computer, phone, copiers, etc.).  A large portion of the day is spent communicating orally in person and by phone.   Normal sight or corrected vision is required to read documents and use standard computer terminals.  Some light lifting may be occasionally required.

We pay competitively. Base salary range is $120,000 - $150,000. Other paid compensation and benefits may be available.

Additional Information

Sonendo offers a competitive benefits package and a collaborative, motivating work environment where you will be encouraged to innovate continuously; This is a place where you will be encouraged to actively participate, and your ideas can have a direct impact on the success of the organization.  If you are interested in applying for this position, please apply online.

No recruiters, please.

Sonendo, Inc. is an Equal Opportunity Employer