Senior Regulatory Affairs Lead – NPD & Clinical Submissions

Intuitive; Sunnyvale (CA); In loco; USD 129.000 - 218.000; Tempo pieno

Descrizione del lavoro

Intuitive, a global leader in robotic-assisted surgery, is seeking a Senior Regulatory Affairs Specialist for NPD Clinical Studies in Sunnyvale, CA. The role focuses on regulatory project management, submissions, and cross‑functional compliance across global markets for complex products.

The position requires 6–8 years in regulatory affairs and a Bachelor's degree in a related field, with on-site work and a defined schedule.

Competenze

• 6–8 years of experience in regulatory affairs and a bachelor’s degree in a relevant discipline, or equivalent combination of education and experience.
• Experience with audits, submissions, and training.
• Expertise in global regulatory requirements and registration processes.

Mansioni

• Develop regulatory strategies for new product development and market entry.
• Advise cross-functional teams on global compliance requirements.
• Lead regulatory submissions, agency communications and strategy for the US and Canada for complex product approvals.
• Provide expert guidance in interpretation of international regulations.
• Represent regulatory affairs team in project meetings.
• Coordinate with OUS global regulatory teams for product registrations and variations.
• Review, approve, and update project documentation.

Conoscenze

Regulatory strategy

Agency negotiations

Global compliance

Project leadership

Documentation review

Formazione

Bachelor's degree in a relevant discipline

Descrizione del lavoro

Intuitive, a global leader in robotic-assisted surgery, is seeking a Senior Regulatory Affairs Specialist for NPD Clinical Studies in Sunnyvale, CA. The role focuses on regulatory project management, submissions, and cross‑functional compliance across global markets for complex products.

The position requires 6–8 years in regulatory affairs and a Bachelor's degree in a related field, with on-site work and a defined schedule.