Quality And Regulatory Compliance Manager

Quality and Compliance Manager

Chirp is seeking an experienced Quality and Compliance manager to join our team, located in Lehi, UT. In this role, you will have the opportunity to build and maintain Chirp’s QMS. You will be the go-to expert for U.S. regulatory strategy and compliance. You’ll lead FDA submission activities, serve as the primary liaison with regulatory authorities, and partner with cross-functional teams to ensure our products meet the highest standards of safety and effectiveness.

Responsibilities include creating and overseeing quality assurance processes, coordinating regulatory submissions, conducting audits, identifying areas for improvement, and collaborating with cross-functional teams to maintain product standards and customer satisfaction.

Key Responsibilities:

• Build, maintain, and improve Chirp’s Quality Management System processes to ensure compliance with FDA, quality, and safety standards.
• Develop and execute regulatory strategies for FDA approval, including preparation and submission of 510(k) applications and related documentation.
• Act as the primary liaison with the FDA and other regulatory authorities.
• Take responsibility for the compilation of other approval-relevant documents including free sales certificates, legalizations, other declarations, and certificates.
• Evaluate design changes for regulatory impact and ensure compliance with design control processes.
• Review packaging and marketing claims for compliance.
• Manage safety-related complaints.
• Monitor regulatory developments (FDA guidance, 21 CFR, ISO 13485, etc.)
• Serve as the regulatory interface with customers, notified bodies, and external partners.
• Support audits and inspections.

Qualifications:

• 5 years of related experience in a similar role in consumer grade medical devices or a related industry.
• Hands-on experience with compliance, documentation processes, quality control procedures, ISO 13485, FDA 21CFR etc. Experience preparing and managing FDA submissions such as 510 (k)
• Proficient in conducting audits and identifying corrective actions.
• Effective communication skills to collaborate with internal teams and communicate regulatory requirements clearly.
• Familiarity with quality management software and tools.
• Bachelor's degree in a relevant field such as Quality Management, Regulatory Affairs, or a related discipline.
• Ability to work on-site in Lehi, UT.
• Strong attention to detail.
• Ability to work in a fast-paced, collaborative environment and manage multiple tasks efficiently.
• Strong work ethic, with a proactive attitude and a willingness to learn.
• Willingness and ability to travel internationally for factory visits.

What We Offer:

At Chirp, our mission since 2015 has been to bring relief to as many people as possible through innovative products designed for everyday use. We are passionate about creating items that enhance people's lives, helping them enjoy their passions and quality time with loved ones. Our team at Chirp values adventure, collaboration, and building meaningful connections with both colleagues and customers. Driven by innovation, we strive to improve well-being through our unique and well-loved relief products.

Among the many benefits our team members enjoy are:

• Competitive salary
• Paid time off
• Health/Dental/Vision Insurance
• 401K
• Collaborative, creative, and growth-focused team environment. We are growing quickly, and you will have real opportunity to make a difference.