Senior Regulatory Affairs Specialist; Hybrid - Sunnyvale, CA

Overview

Our Customer is a corporation that develops, manufactures, and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery. Founded in 1995, their goal was to create innovative, robotic‑assisted systems that help empower doctors and hospitals to make surgery less invasive than an open approach. Working with top medical professionals, they continue to develop new minimally invasive surgical platforms and future diagnostic tools to solve complex healthcare challenges worldwide.

Senior Regulatory Affairs Specialist (Contract Basis) – Hybrid (3 days on‑site, 2 days remote per week) located in Sunnyvale, CA.

• Provide regulatory guidance to product teams and develop regulatory plans.
• Review and approve product design control documentation.
• Determine regulatory pathways and formulate regulatory strategies for 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 FDA 510(k) pre‑market notifications, Letters to File, pre‑submissions, and Health Canada submissions.
• Coordinate with technical experts to gather additional data and prepare responses to regulatory agency requests.
• Provide risk‑based regulatory guidance to projects and issues, ensuring cross‑functional alignment and resolution.
• Collaborate with international counterparts to support global regulatory submissions, approvals, and implementation rollouts.
• Maintain regulatory filings and licenses.

• Minimum 8 years of regulatory affairs experience in a medical device environment.
• Strong understanding of U.S. medical device regulations, Health Canada guidance, and EU MDR.
• Strong knowledge of product lifecycle management, design controls, risk management, verification and validation, and product labeling requirements.
• Experience preparing regulatory submissions, including FDA 510(k) submissions.
• Strong ability to assess the regulatory impact of design and process changes.
• Ability to manage multiple projects in a fast‑paced environment.
• Strong verbal and written communication skills.
• Ability to translate technical documentation into internal documentation and regulatory submissions.
• Strong interpersonal, negotiation, and influencing skills.
• Strong collaboration and cross‑functional partnership skills.
• Proactive mindset with commitment to staying current on regulatory landscape developments.
• Bachelor’s degree or higher in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Pharmacy, or equivalent experience.

• Master’s degree in Regulatory Science or related field.
• Regulatory Affairs Professionals Society Regulatory Affairs Certification (RAC).

Contractor benefits available through a third‑party Employer of Record, including Medical, Dental, Vision, and 401(k). Salary range is competitive, with most candidates hired at the median of the range based on experience and qualifications.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.