Regulatory Affairs Specialist EMEA

• Ways of Working:
  Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.
• Employee Type:
  Employee
• Global Job Level (HCM):
  Professional 3 (9)

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.

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…