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Lead Specialist, Regulatory Affairs at Stryker - ApplyBlast

Lead Specialist, Regulatory Affairs

Stryker

4 months ago

4.0 on Glassdoor

Tokyo, Japan

Hybrid

Full Time

Senior

1 applicant

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About this role

This role involves assessing regulatory intelligence, developing compliance strategies throughout the product lifecycle, and engaging with regulatory authorities to navigate approval pathways. The position requires identifying market access requirements, evaluating product submissions, and guiding cross-functional teams on global regulatory obligations.

Responsibilities

Assess regulatory intelligence to develop global strategies
Navigate approval pathways and manage submission filings
Advise cross-functional teams on compliance requirements
Evaluate product claims and clinical data for regulatory acceptance
Engage with regulatory authorities during audit and review processes

Skills

Qualifications

BS in Engineering or ScienceMS in Regulatory ScienceRegulatory Affairs Certification (RAC)

About Stryker

stryker.com

Headquarters

Portage, Michigan, United States

Company Size

10001+ employees

Founded

1941

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Stryker is a global medical technology company that develops and sells a broad range of medical devices, equipment, and services. The company serves healthcare markets across the Americas, Asia Pacific, Europe, and the Middle East & Africa. Stryker's products span areas including surgical equipment, orthopedics, and medical instruments.