Senior Regulatory Affairs Specialist
vor 2 Wochen
At Intuitive Surgical, we are dedicated to advancing minimally invasive care through innovative technology and intelligent design. Our mission is to empower physicians to heal without constraints, and we strive to foster a culture of inclusivity and diversity within our team.
As a pioneer in robotic-assisted surgery, we have worked with hospitals and care teams around the world to address some of healthcare's most pressing challenges. Our commitment to making a difference is reflected in our values, which prioritize integrity, a strong capacity to learn, and a passion for innovation.
Job SummaryThe Senior Regulatory Affairs Specialist plays a critical role in our Regulatory Affairs Department, providing advanced regulatory support for New Product Development (NPD) and sustaining operations across designated Business Units. This position requires a deep understanding of EU and global medical device regulations, as well as significant experience in managing regulatory submissions and compliance activities.
Key Responsibilities- Lead regulatory efforts in NPD projects and sustaining operations for Business Units, including preparing, coordinating, and maintaining EU Medical Device dossiers, CE Mark submissions, and associated Technical Documentation, ensuring compliance with EU regulations.
- Act as a lead contact for Notified Bodies, representing the company's regulatory strategies, addressing inquiries, and ensuring compliance with applicable regulations.
- Manage the preparation, submission, and maintenance of EU Medical Device and geographic-specific registration dossiers, ensuring alignment with business objectives, timely regulatory approvals, and up-to-date records.
- Collaborate in the development and implementation of EU regulatory strategies for new product introductions, product changes, and new indications, ensuring alignment with business goals.
- Provide regulatory advice to cross-functional teams, ensuring product development and changes are in line with current regulatory requirements.
- Monitor and communicate changes in Global and EU medical device regulations and standards, updating company policies and procedures as necessary to maintain compliance.
- Coordinate registration strategy with Sales and Marketing stakeholders, aligning regulatory requirements with business objectives.
- Lead or participate in process improvement initiatives aimed at enhancing regulatory submission efficiency and effectiveness within the Regulatory Affairs Department.
- A minimum of 8+ years of experience in regulatory affairs within the medical device industry, with significant experience in EU regulations.
- A 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.
- In-depth understanding of Global medical device regulations, including ISO 13485, European Medical Device Directive (93/42/EEC), and Medical Device Regulation (2017/745/EU).
- Proven experience leading EU submissions for NPD projects and sustaining activities, including preparing CE Mark documentation and managing interactions with Notified Bodies.
- Strong organizational, leadership, and interpersonal skills, with a proactive approach to problem-solving, a sense of urgency, and the ability to collaborate effectively within international teams and across departments.
- A meticulous attention to detail, ensuring accuracy and completeness in all work-related tasks.
- Knowledge of EU regulations and directives relevant to product compliance, such as RED, ROHS, and the Waste Framework Directive.
- Proficiency in English, with a minimum of C1 level proficiency in both written and spoken forms.
- General computer proficiency, including Microsoft Office Suite (Word, Excel, PowerPoint) and Outlook.
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