Senior Regulatory Affairs Program Lead (Software/OTTAVA)

This senior regulatory affairs role will help drive US and international regulatory approval strategies for an advanced surgical robotics portfolio. You will lead regulatory planning and execution throughout the product lifecycle, from development and submission through approval and post-market activities. Working closely with engineering, clinical, and cross-functional teams, you will ensure that product documentation and development activities meet applicable regulatory requirements. You will provide strategic guidance on software-enabled electromechanical medical devices, including robotics systems and connected technologies. The position also involves preparing and authoring FDA submissions, supporting health authority interactions, and navigating evolving regulatory standards. This is an opportunity to contribute to innovative surgical technologies while helping expand patient access to advanced medical solutions.

• Bachelor's degree required; an advanced degree is strongly preferred.

• At least 6 years of regulatory affairs experience in the medical device industry, including experience with software-enabled systems.

• Proven track record of obtaining regulatory approvals, such as 510(k) clearances, IDE approvals, and De Novo authorizations.

• Experience supporting US market access and regulatory submissions.

• Strong understanding of regulatory requirements for medical device development, including the ability to assess new and changing regulations and determine their impact on projects.

• Demonstrated ability to lead multiple complex projects and manage detailed regulatory activities.

• Excellent cross-functional communication and collaboration skills, with the ability to influence stakeholders across regulatory and other business functions.

• Strong independent judgment and strategic thinking, including the ability to interpret regulatory guidance, requirements, and industry trends and translate them into practical business strategies.

• Advanced analytical and problem-solving skills, flexibility, and comfort working through ambiguity.

• Willingness to travel up to 10%.

Preferred Qualifications:

• Experience preparing for and participating in health authority meetings.

• Background in vision systems, robotics, or connected medical platforms.

• Familiarity with the IEC 60601 series and ISO 10993-1 standards.

• Strong knowledge of FDA regulatory requirements relating to medical device software and cybersecurity.