International Regulatory Affairs Specialist - Hybrid/Remote

Stryker Corporation; Irvine (CA); Hybrid; USD 110,000 - 183,000; Full time

Job summary

Stryker Corporation in Irvine, CA is seeking an International Regulatory Affairs Specialist to ensure timely and compliant global product registrations. You will drive operational excellence, collaborate with global teams, and influence access to safe, effective products worldwide.

The role supports hybrid or onsite work arrangements, with requirements to reside within commuting distance of Irvine, CA. A strong background in regulatory affairs and international submissions is essential.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Science, or a related discipline.
• Minimum 4 years of regulatory affairs experience in medical device, biotech, pharma, or related regulated industry.
• Experience with international regulatory submissions and compliance across product lifecycle.

Responsibilities

• Evaluate products, changes, and manufacturing changes to determine regulatory classification and submission requirements.
• Assess regulatory intelligence and evolving regulations to support global strategies.
• Advise cross-functional teams on regulatory requirements across lifecycle stages.

Skills

Regulatory affairs

Cross-functional collaboration

Regulatory strategy

Education

Bachelor's degree in Engineering or Life Sciences

Master’s degree in Regulatory Science

Job description

Stryker Corporation in Irvine, CA is seeking an International Regulatory Affairs Specialist to ensure timely and compliant global product registrations. You will drive operational excellence, collaborate with global teams, and influence access to safe, effective products worldwide.

The role supports hybrid or onsite work arrangements, with requirements to reside within commuting distance of Irvine, CA. A strong background in regulatory affairs and international submissions is essential.