Global Regulatory Affairs Lead – Medical Devices (Remote)

Stryker; Mahwah (NJ); Remote; USD 110,000 - 190,000; Full time

Job summary

Stryker in the United States is seeking a Regulatory Affairs professional to lead global regulatory strategies for medical devices across the product lifecycle. You will partner with cross-functional teams to support development, regulatory submissions, market access, and ongoing compliance in U.S. and international markets.

This remote role prefers candidates in the U.S. Eastern Time Zone and involves preparing submissions, reviewing technical documents, and guiding labeling and post-market

Qualifications

• Minimum 4 years of experience in an FDA-regulated industry.
• Minimum 3 years of Regulatory Affairs experience; FDA submissions experience.
• Bachelor’s degree in Engineering, Sciences, Regulatory Affairs, or related field.

Responsibilities

• Develop and execute global regulatory strategies for new products and lifecycle changes.
• Collaborate with product teams to embed regulatory requirements in development phases.
• Evaluate classifications, pathways, and jurisdictional requirements for medical devices.
• Prepare regulatory submissions including FDA filings and international registrations.
• Review technical, quality, preclinical and clinical data for submission readiness.
• Lead interactions with regulators and notified bodies, managing agency communications.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Quality/regulatory docs

Education

Bachelor's degree in Engineering, Sciences, Regulatory Affairs

Job description

Stryker in the United States is seeking a Regulatory Affairs professional to lead global regulatory strategies for medical devices across the product lifecycle. You will partner with cross-functional teams to support development, regulatory submissions, market access, and ongoing compliance in U.S. and international markets.

This remote role prefers candidates in the U.S. Eastern Time Zone and involves preparing submissions, reviewing technical documents, and guiding labeling and post-market