Sr Regulatory Affairs Specialist - temporary

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 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.

The Senior Regulatory Affairs Specialist plays an important role within the Regulatory Affairs Department, focusing on 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, and significant experience in managing regulatory submissions and compliance activities. The Senior Regulatory Affairs Specialist collaborates with cross[1]functional teams, offering expert guidance on regulatory matters, while contributing to the success of product launches and ongoing operations.

• 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[1]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.

• Assist in maintaining and enhancing the Quality Management System (QMS), including CAPA, Management Review, and participation in internal / external audits and inspections, ensuring compliance with ISO 13485 and other regulatory requirements.
• Mentor and guide junior regulatory team members, contributing significantly to their development and the continuous improvement of the Regulatory Affairs department.
• Provide regulatory support to other departments, including R&D, engineering, and…