Senior Regulatory Affairs Specialist (Hybrid - Sunnyvale, CA)

Responsibilities

• 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.
• Audit 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) premarket notifications, Letters to File, pre-submissions, and Health Canada submissions.
• Collaborate 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.

Requirements

• 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.

Qualifications

• Bachelor’s degree or higher in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Pharmacy, or equivalent experience.
• Preferred: Master’s degree in Regulatory Science or related field. Regulatory Affairs Professionals Society Regulatory Affairs Certification (RAC).

Pay

We offer a competitive salary range for this position. Most candidates who join our team are hired at the median of this range, ensuring fair and equitable compensation based on experience and qualifications.

Schedule

This role is hybrid (3 days on-site and 2 days remote/week) in Sunnyvale, CA.