Regulatory Affairs Specialist EMEA

Job description

Primary Function of Position: The Regulatory Affairs Specialist plays an important role within the Regulatory Affairs Department, focusing on providing advanced regulatory support for New Product Development (NPD), market expansion and sustaining operations across designated Business Units. This position requires advanced understanding of EU and global medical device regulations, and experience in managing regulatory submissions and compliance activities. The Regulatory Affairs Specialist collaborates with cross-functional teams, offering guidance on regulatory matters, while contributing to the success of product launches and ongoing operations. Roles and Responsibilities: Assess regulatory impact within EMEA (EU/EEA, Middle East, Africa) and support implementation of new markets, product expansion in existing markets, and new product introduction. Provide guidance to cross-functional teams, ensuring product development and changes are in line with current regulatory requirements. Manage the preparation, submission, and maintenance of EMEA medical device registration dossiers, ensuring compliance with local regulations, timely regulatory approvals, and up-to-date records. Coordinate registration strategy with cross-functional partners such as Product Lifecycle Management, Supply Chain, Marketing, and Commercial teams, aligning regulatory requirements with business objectives. Prepare and review regulatory correspondence, Letters of Notification, declarations, certificates, and supporting technical documentation. Monitor and perform sustaining activities including renewals, amendments, and change notifications for assigned markets. Perform regulatory impact assessments for changes throughout the product lifecycle such as design modifications, labeling updates, software releases, etc. Maintain registration trackers, regulatory databases, and product registration records. Monitor and evaluate changes in medical device regulations and standards for assigned markets, updating departmental policies and procedures as necessary to maintain compliance. Coordinate and support responses to regulatory authority inquiries and requests for additional information relevant to team activities. Support audits, inspections, and compliance activities as needed. Address regulatory inquiries from cross-functional partners for assigned markets, providing timely and accurate information. Identify opportunities and participate in projects to improve efficiency, compliance, and process standardization. Perform other regulatory tasks and projects as assigned, ensuring regulatory compliance across regional markets. Required Knowledge, Skills, and Experience: Bachelor's or Master's degree in Engineering, Medical Technology, or a related field is highly preferred, though practical experience in a similar role will be considered. Proficiency in English, with a minimum of C1 level proficiency in both written and spoken forms. 5+ years of experience in regulatory affairs within the medical device industry, with experience or exposure in the following areas: Medical device registration lifecycle management, including new registrations, renewals, amendments and change management. Regulatory impact assessments and change notification strategies. Advanced understanding of Global regulatory requirements and standards for Medical Devices relevant to product compliance (e.g., EU MDR 2017/745, ISO 13485, RoHS, etc.). Detail-oriented with strong project management and organizational skills. Ability to lead resolutions across international teams to effectively address project risks. Proactive approach to problem-solving, and collaborative/supportive in team setting. 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 leading company in the field of 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.