Global Regulatory Affairs Specialist | Hybrid (Irvine)

Regulatory Jobs; Irvine (CA); Hybrid; USD 110,000 - 183,000; Full time

Job summary

Stryker Corporation is seeking a Staff International Regulatory Affairs Specialist in Irvine, CA to advance global product registrations through regulatory pathways and across diverse markets. This role emphasizes collaboration with global teams to ensure compliant, timely submissions and to deliver safe, effective products to patients worldwide.

The position supports a hybrid work model, requiring proximity to Irvine for onsite days, and involves interaction with regulatory authorities,

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Science, or related.
• 4+ years regulatory affairs experience in medical device, biotechnology, pharmaceutical, or related regulated industry.
• Experience preparing and supporting international regulatory submissions and regulatory compliance activities.
• Experience interpreting and applying regional and global regulatory requirements across product development and lifecycle management.

Responsibilities

• Evaluate products and changes to determine regulatory classification and submission pathways.
• Assess regulatory intelligence and evolving regulations for global strategies.
• Advise cross-functional teams on regulatory requirements throughout the product lifecycle.
• Identify regulatory risks and develop compliant solutions and action plans.
• Prepare and submit regulatory filings and notifications in electronic and paper formats.
• Monitor authority review processes and support agency meetings and inspections.
• Build relationships with global regulatory partners to support registrations.
• Review documentation for submission readiness and compliance.
• Develop internal monitoring to optimize submission planning.

Skills

Regulatory Affairs

Regulatory Submissions

Cross-functional Collaboration

Education

Bachelor's degree in Engineering, Life Sciences, Regulatory Science, or related

Job description

Stryker Corporation is seeking a Staff International Regulatory Affairs Specialist in Irvine, CA to advance global product registrations through regulatory pathways and across diverse markets. This role emphasizes collaboration with global teams to ensure compliant, timely submissions and to deliver safe, effective products to patients worldwide.

The position supports a hybrid work model, requiring proximity to Irvine for onsite days, and involves interaction with regulatory authorities,