Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible. Passionate people who want to make a difference drive our culture—our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real-world experiences to help us think in new ways. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients.

Job Description
Primary Function of Position: The Post Market Surveillance Specialist supports the Regulatory Department by reviewing, evaluating, and performing follow up activities on all product complaints, determining if they require vigilance reporting and identifying supporting data. Main activities Evaluates incoming complaint information and maintains the records in the electronic database as per company procedures and processes. Conducts follow-up investigations with internal resources, field personnel and/or customer as appropriate to gather additional information for reported events and assist in data collection for trending purposes. Collect, trend, and escalate data related to Post Market Surveillance. Other regulatory tasks and projects may be assigned as necessary. Knowledge / understanding of the European Medical Device Regulation (EU) ** (EU MDR), applicable MDCG guidance, UK Medical Devices Regulations *
* (as amended), including applicable MHRA vigilance requirements, and the Swiss Medical Devices Ordinance (MedDO),



including applicable Swissmedic vigilance requirements. Understanding of quality records requirements and how they apply to complaint files and post-market surveillance reports. A Bachelor's degree or Swiss CFC (Health Sciences preferred). 6 months – 2 years of experience in complaint handling for medical devices. Demonstrate organizational and planning skills, including being action-oriented, maintaining a sense of urgency, and driving results. Demonstrate good communication skills over the phone, in person and in writing. Ability to guide customers in providing key relevant data for case management. Fluent in written and spoken English, Spanish and Portuguese. General computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook). Basic knowledge of US FDA 21 CFR Parts 803 and 806, and 21 CFR Part 820 (Quality Management System Regulation – QMSR), would be a plus. Experience with software such as TrackWise, ERP/CRM (e.g., SAP) or Salesforce is a plus. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. Export Controls Disclaimer: In accordance with the U.
S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status. ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process). For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's start date, which may or may not be versátil, and within a timeframe that does not unreasonably impede the hiring need. Shift: Day

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