EU Post Market Surveillance Specialist

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. Roles and Responsibilities: Main activities Evaluates incoming complaint information and maintains the records in the electronic database as per company procedures and processes. Works closely with Customer Service to support the product return process as it relates to complaints. Processes, records, and closes complaint-handling activities in a timely manner. 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. Determines reportability of complaints per regulatory reporting requirements. Acts as an interface between EMEIA customer support team, Regulatory Post Market Surveillance team in US and European customers, including distributors. Additional activities Evaluates and reports device malfunctions involving company products to the European regulatory agencies. Collect, trend, and escalate data related to Post Market Surveillance. Assists and supports other employees, teams, and field personnel as necessary. Other regulatory tasks and projects may be assigned as necessary. Qualifications Required Knowledge, Skills, and Experience: Knowledge / understanding of the European Medical Device Regulation (EU) 2017/745 (EU MDR), applicable MDCG guidance, UK Medical Devices Regulations 2002 (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. Ability to handle multiple tasks, prioritize and schedule work to meet business needs. 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. Demonstrate good interpersonal skills, the ability to work with others in an international team environment, and effective interactions in cross-departmental teams. Ability to guide customers in providing key relevant data for case management. Attention to detail, with emphasis on accuracy and completeness. 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. Intuitive is an Equal Employment Opportunity Employer. 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. U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (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 flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate’s experience, knowledge and skills. Compensation will be based primarily on the job level at which the role is filled and the candidate’s qualifications, consistent with applicable law. 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. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. 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. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let’s advance the world of minimally invasive care.