Remote Global Regulatory Affairs Specialist

Stryker; United States; Remote; USD 77,000 - 183,000; Full time

Job summary

Stryker is seeking a Staff Regulatory Affairs Specialist, Mako and Enabling Technologies, to lead regulatory activities across the product lifecycle. This remote role focuses on global regulatory submissions, market access, and ongoing compliance for U.S. and international markets.

A strong background in FDA submissions and cross-functional collaboration is essential. Preferred candidates hold RAC and/or a Master’s in Regulatory Affairs, with experience in Class II/III medical devices and direct

Qualifications

• Bachelor’s degree in Engineering, Sciences, Regulatory Affairs, or related field.
• Minimum 4 years of experience in an FDA-regulated industry.
• Minimum 3 years of Regulatory Affairs experience.
• Experience preparing regulatory submissions for product approvals.

Responsibilities

• Develop and execute global regulatory strategies for new products, changes and lifecycle management.
• Ensure US, European, and international regulatory requirements are integrated across development phases.
• Evaluate classifications, pathways, and jurisdictional requirements for medical devices and related tech.
• Author and submit regulatory filings, including FDA submissions and international registrations.
• Review quality, preclinical, and clinical documentation for submission readiness and compliance.
• Collaborate with global regulatory affiliates on registrations, market expansions, and post-market activities.
• Lead interactions with regulatory authorities and notified bodies, including responses and agency communications.
• Review labeling and marketing materials for regulatory compliance and mentor junior staff.

Skills

Regulatory Affairs

FDA Submissions

Regulatory Strategy

Education

Bachelor’s degree in Engineering/Sciences/Regulatory Affairs

Job description

Stryker is seeking a Staff Regulatory Affairs Specialist, Mako and Enabling Technologies, to lead regulatory activities across the product lifecycle. This remote role focuses on global regulatory submissions, market access, and ongoing compliance for U.S. and international markets.

A strong background in FDA submissions and cross-functional collaboration is essential. Preferred candidates hold RAC and/or a Master’s in Regulatory Affairs, with experience in Class II/III medical devices and direct