Mindray North America · 23 hours ago
Sr Complaint/Regulatory Affairs Associate
Mahwah, NJ
Full-time
Onsite
Mid, Senior Level
3+ years expMindray North America is a global leader in medical technology, delivering advanced patient monitoring systems and other solutions. The Complaint/Regulatory Affairs Associate plays a key role in managing product complaints and ensuring regulatory compliance, focusing on reviewing and documenting complaint data and supporting regulatory functions.
Health CareManufacturingMedical Device
Responsibilities
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
Qualification
Required
Bachelor's degree required
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.)
Benefits
401(k) with company match
Tuition reimbursement
Paid time off
Disability coverage
FSA/HSA options
Company
Mindray North America
Mindray North America is a company that develops, manufactures, and markets medical devices worldwide.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
JoAnn Brunetti
Director of Global Corporate Partnerships
Recent News
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