Senior Staff Regulatory Affairs Specialist

Senior Staff Regulatory Affairs Specialist

Irvine, California

As a Senior Staff Regulatory Affairs Specialist , you will influence global regulatory strategy across the full product lifecycle while partnering closely with product development, quality, and clinical teams. This role offers meaningful impact, technical depth, and the opportunity to shape regulatory outcomes that enable innovation and market access.

Work Flexibility: Hybrid or Onsite
Hybrid candidates must reside within commuting distance of Irvine, CA and be able to work onsite several days per week.

What You Will Do

• Assess global regulatory intelligence to support the development and maintenance of local, regional, and global regulatory strategies across the product lifecycle.
• Evaluate regulatory requirements related to product classification, jurisdiction, submission pathways, and compliance activities to enable market access.
• Provide regulatory guidance to product development teams across concept, development, manufacturing, marketing, and post‑market phases.
• Anticipate regulatory risks and obstacles and develop solutions to support timely product approvals and lifecycle changes.
• Prepare, submit, and manage regulatory submissions and communications with regulatory authorities in accordance with applicable requirements.
• Monitor regulatory authority review progress and support interactions such as meetings, panels, and advisory engagements.
• Assess quality, preclinical, and clinical documentation to ensure acceptability for regulatory filings and alignment with regulatory strategy.
• Support the development, implementation, and training of regulatory procedures to strengthen organizational compliance.
• Development and review of advertising/promotional collateral to support commercial needs.

What You Will Need

Required Qualifications

• Bachelor’s degree in Engineering, Science, or a related discipline.
• 6+ years of experience in regulatory affairs within a regulated industry.
• Experience supporting regulatory submissions and approvals across the product lifecycle.

Preferred Qualifications

• Master’s degree in Regulatory Science or a related field.
• Regulatory Affairs Certification (RAC).
• Experience interacting directly with regulatory authorities in the United States or international markets.

• $126,600 - $210,900 USD Annual

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.