The Global Complaint Manager is responsible for managing customer complaints classified as potential incidents, ensuring full compliance with international regulations (e.g., FDA 21 CFR 820, ISO 13485, MDR).
Key responsibilities include:
- Leading end-to-end complaint handling: intake, investigation, RCA, CAPA, closure, and reporting
- Collaborating with global partners (distributors, subsidiaries) to gather data and provide guidance
- Integrating a CRM-based complaint handling tool to enhance traceability and compliance
- Ensuring accurate documentation, trend analysis, and continuous process improvement
- Supporting regulatory submissions, audits, and Post-Market Surveillance (PMS) activities including PSUR
- Conducting regulatory and clinical assessments of potential incidents
- Providing training to internal teams and external partners on complaint handling procedures
Requirements
- Bachelor’s in Life Sciences, Engineering, or related field (advanced/clinical degree preferred)
- 5+ years of experience in complaint handling within the medical device industry, with a focus on adverse events
- Strong understanding of global medical device regulations and risk management principles
- Experience with eQMS, PMS data analysis, PSURs, and regulatory assessments
- Proficiency in RCA tools (5 Whys, Fishbone, etc.) and complaint management software
- Excellent communication, documentation, and analytical skills
- Fluency in English (written and spoken); additional languages a plus
- Familiarity with class IIb HW/SW products, audit processes, and clinical data review
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What We Do
You already know we create amazing technology that helps millions around the world to live better, more confident lives. You also know that we are at the top of the medical aesthetic market.
But we’re here to tell you we are way more than that.
We realized that in the modern life, a better way to make innovative technology, is understanding what our partners and their patients really want. To put people and their needs first. So we became better at listening and translating the true needs of your patients into outstanding and cutting-edge technology.
We are transforming together. With you. This is what we been doing for the last 20 years. This is what got us to be a leading player in the medical aesthetics field. We take pride being number 1 in China and number 3 globally, and we owe this accomplishment to our people, our partners and our daring spirit. We infuse this spirit in everything we do and we invite you to join us.
Whatever comes next we are there.
Alma Lasers is a global innovator of laser, light-based, radiofrequency and ultrasound solutions for the aesthetic and surgical markets.
Alma Lasers has been at the forefront of multi-technology systems, revolutionizing existing treatment methods and working to serve the varied and growing needs of both patients and practitioners around the world.
With offices, R&D and manufacturing facilities on three continents and distributors around the world, Alma's mission is to provide modular, cost-effective and high-performance systems based on the very latest clinical research and cutting-edge technology. We enable practitioners to offer safe, effective and profitable aesthetic and surgical treatments to their patients, while allowing patients to benefit from the capabilities of state-of-the-art, clinically proven technologies and methods.
