Sr Complaint​/Regulatory Affairs Associate

Description

Sr Complaint/Regulatory Affairs Associate in Mahwah, NJ.

Join Mindray North America and help shape the future of patient care.

Mindray is a global leader in medical technology, delivering advanced patient monitoring systems, anesthesia machines, ventilators, and ultrasound solutions trusted in hospitals and critical care environments worldwide. Unlike many larger competitors, Mindray combines cutting‑edge innovation with unmatched value, giving healthcare providers access to reliable, feature‑rich technology without compromise. Our culture is built on collaboration, integrity, and a drive to equip caregivers with the tools they need to deliver exceptional care.

Fast facts about Mindray:

• Founded in 1991, with 14,000 employees worldwide
• 8 global R&D centers, investing ~10% of annual revenue into innovation
• North American headquarters in Mahwah, NJ, with 40+ international subsidiaries

The Complaint/Regulatory Affairs Associate plays a key role in managing product complaints and ensuring regulatory compliance. This position is responsible for reviewing, investigating, and documenting complaint data, as well as supporting Medical Device Reports (MDRs), corrections and removals, and other Quality System Regulation (QSR) activities. The role requires strong attention to detail, analytical skills, and the ability to collaborate across departments to ensure accuracy, compliance, and continuous improvement of complaint processes.

• Review, document, and process complaints and Medical Device Reports in accordance with regulatory and internal procedures.
• Investigate complaint data using technical sources such as CAPA, SCAR, and historical records.
• Collaborate with colleagues in Mahwah and abroad to identify root causes and corrective actions related to complaint activities.
• Support Regulatory Affairs and Quality functions in maintaining compliance with FDA medical device regulations.
• Participate in process improvement initiatives to enhance complaint handling efficiency and accuracy.
• Prepare and maintain regulatory documentation and assist with external reporting when necessary.

• Education: Bachelor’s degree required.
• Experience: 3–5 years of experience in a regulated industry, preferably medical devices, with working knowledge of FDA complaint handling requirements.

• Strong organizational, analytical, and writing abilities.
• Exceptional attention to detail and follow‑up skills.
• Ability to multitask and manage multiple priorities in a fast‑paced environment.
• Excellent communication and interpersonal skills.
• Proficiency with Microsoft Office applications (Word, Excel, etc.).

Mindray North America offers a competitive compensation package and comprehensive benefits, including a 401(k) with company match, tuition reimbursement, paid time off, disability coverage, FSA/HSA options, and more—all within a dynamic, supportive, and collaborative work environment.

Mindray North America is an Equal Opportunity Employer M/F/D/V. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability, or any other legally protected status and will not be harassed or discriminated against.