Careers

Job Brief

Candela is recognized globally for its innovating energy-based technologies that change lives and our new brand embodies our continued commitment to innovating medical aesthetic treatment solutions based on solid science and effective outcomes.

We aspire to provide the highest levels of clinical, technical and customer support, and continue to build on the longstanding partnerships of trust we’ve established with physicians, their practices and the patients they treat.

Every role is important at Candela :

The Complaint Manager is responsible for all aspects of the Global Complaint Management process. The role will manage a post-market surveillance team who execute the complaint handling process. The Post-Market Surveillance processes are activities mainly related to patient safety risk assessments, Medical Device/Vigilance reporting, coordinating the Customer Complaints process, and support worldwide compliance. With limited supervision, assist the organization in the required areas as listed in General Manage a complaint group.

• Manage the handling, investigation and resolution of all product performance complaints and patient-related field events in a manner that complies with regulatory requirements
• Manage the complaint handling process, including but not limited to complaint procedures and training of post-market surveillance team
• Champion the efforts to streamline complaint handling process; improve visibility and issue resolution
• Establish and monitors complaint metrics and drives process improvements based on performance trends.
• Drive product quality improvements and support quality-based processes to ensure the high-quality products and solutions, as well as compliance with all applicable regulations and requirements.
• Ensure proper analysis of product quality, safety, and reliability issues and effective communication to management and other functions.
• Review completed complaint files to ensure compliance to business requirements as well as regulatory requirements
• Initiate and support corrective or preventive actions as needed.
• Support and participate in internal and external audits, risk management summaries and health hazard evaluations
• Work closely with Regulatory Affairs to ensure timely completion of MDR and Vigilance reporting, as well as initial, supplemental and final incident reports to regulatory authorities within specified timelines
• Leading the team as a people manager, motivating the team, and ensuring through good leadership that defined performance outcomes are ensured.

Essential Skills to be a top contributor in this role:

• Bachelor’s degree, plus a minimum of 5 years of related experience in the medical device or another regulated industry
• Minimum 5-7-years’ experience in QA systems implementation
• Expert understanding of appropriate global medical device regulations, requirements and standards, including Quality Management System (ISO 13485), MDSAP (Medical Device Single Audit Program), Medical Device Regulations (21 CFR 820), Corrections and Removals (21 CFR 805), EU Medical Device Direction (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, ANVISA, and applicable regulatory requirements and standards
• Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change movement
• Communication in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to manager
• Ability to analyze information and come to conclusions based on presented data
• Ability to communicate effectively both orally and in writing
• Self-motivated, manage time working on multiple projects simultaneously
• Demonstrated competency in computer skills: MS office applications, query tools, and enterprise database systems, Service Max is a plus
• Must be able to communicate appropriately and adequately to all management levels, including group presentation experience