Senior Regulatory Affairs Specialist

Regulatory Jobs; Sunnyvale (CA); Presencial; USD 140 000 - 190 000; Tempo integral

Resumo da oferta

Intuitive Surgical in Sunnyvale, CA, seeks a Sr. Regulatory Affairs professional to lead regulatory strategies across product lifecycle for robotic-assisted surgery devices. You will develop regulatory plans, review design controls, and coordinate submissions with FDA and other agencies.

The role requires 8+ years in medical device regulatory affairs, deep knowledge of US FDA regulations and EU MDR, and strong cross-functional collaboration to ensure compliant, timely product introductions.

Qualificações

• 8+ years regulatory affairs in medical devices.
• Knowledge of US FDA regulations and EU MDR, including digital/software projects.
• Experience with product lifecycle management, design controls, risk management, verification and validation, and labeling requirements.
• Ability to manage multiple projects in a fast-paced environment.
• Strong written and verbal communication; translate technical docs into regulatory submissions.
• Team player with professional demeanor.
• Willingness to develop regulatory knowledge continuously.

Responsabilidades

• Serve as global regulatory liaison for product and project teams.
• Develop regulatory plans; review/approve design control documentation.
• Determine regulatory pathways for US and Canada; assess impact on design/materials/packaging; lead global strategies.
• Lead submissions, including FDA 510(k) and Letters to File.
• Coordinate with subject matter experts and respond to regulatory agencies.
• Provide regulatory input to projects to ensure cross-functional alignment.
• Collaborate with international counterparts for global submissions and rollouts.

Conhecimentos

Regulatory affairs

FDA 510(k) knowledge

EU MDR experience

Design controls

Risk management

Documentation writing

Interpersonal skills

Formação académica

Biomedical/Engineering degree

Master's in Regulatory Science

Descrição da oferta de emprego

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at

Intuitive

. As a global leader in

robotic-assisted surgery

and

minimally invasive care

, our technologies—like the

da Vinci surgical system

and

Ion

—have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help

transform the future of healthcare

, you’ll find your purpose here.

Primary Function of Position

The Sr. Regulatory Affairs serve as the primary regulatory representative on product and project

teams supporting product lifecycle management activities. Responsibilities include developing

regulatory plans, reviewing design input/output documentation, identification of applicable

standards and guidance documents, performing regulatory assessments to determine the impact

of design/process changes, preparing regulatory submissions, maintaining regulatory filings and

licenses and interacting with regulatory agencies

Essential Job Duties

• Serve as the global regulatory liaison and primary point of contact for product and project teams.
• Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.
• Determine regulatory pathways and formulate regulatory strategies for the U.S. and Canadian markets. Assess regulatory impact on design, materials, labeling, packaging, manufacturing processes, and facility changes. Influence and lead global regulatory strategies.
• Author and lead regulatory documentation and submissions, including U.S. FDA 510(k) premarket notifications, internal Letters to File, pre-submissions with minimal supervision.
• Coordinate with technical experts to provide additional data/information requested by regulatory agencies and prepare responses to facilitate regulatory approvals.
• Provide risk-based guidance and regulatory input to projects and issues, ensuring cross-functional alignment and resolution.
• Collaborate with international counterparts to support global regulatory submissions, approvals, and implementation rollouts.

Required Skills and Experience

• Minimum 8 years of regulatory affairs experience working in a medical device company (can be in combination with a regulatory affairs master degree; e.g., Masters in Regulatory Science)
• In-depth understanding of US Medical Device regulations and EU MDR, especially as it related to Digital and SW related projects.
• Regulatory working knowledge of product lifecycle management, design controls, risk management, verification and validation, and product labeling requirement
• Ability to work in a fast-paced environment and handle multiple projects simultaneously
• Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions
• Team player who seeks to help and learn from colleagues seeing the department success as their own
• Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
• Proactively seeks to develop and become well-versed within the regulatory landscape.

Required Education and Training

Minimum B.S. or higher in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or Pharmacy preferred. Non-technical degrees with equivalent complex medical device experience are acceptable.

Working Conditions

None

Preferred Skills and Experience

• RAPS Regulatory Affairs Certification (RAC) is a plus.