Senior Global Regulatory Affairs Specialist - Remote

Stryker; Mahwah (NJ); Remote; USD 120,000 - 190,000; Full time

Job summary

Stryker is seeking a Staff Regulatory Affairs Specialist for Mako and Enabling Technologies. This remote role provides regulatory leadership across the product lifecycle, partnering with cross-functional teams to support submissions and global market access.

You will develop regulatory strategies, prepare FDA submissions, review documentation, and interact with global authorities while mentoring junior staff in regulatory processes and best practices.

Qualifications

• Bachelor’s degree in Engineering, Sciences, Regulatory Affairs, or a related field is required.
• 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, product changes, and lifecycle management activities.
• Participate in product development teams to ensure regulatory requirements are incorporated across development phases.
• Evaluate product classifications, regulatory pathways, and jurisdictional requirements for medical devices and related technologies.
• Author and submit regulatory filings, including FDA submissions and international registrations.
• Review quality, preclinical, and clinical documentation for submission readiness and regulatory compliance.
• Partner with global regulatory affiliates to support registrations 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 submissions

FDA-regulated industry experience

Cross-functional collaboration

Education

Bachelor’s degree in Engineering, Sciences, Regulatory Affairs, or a related field

Job description

Stryker is seeking a Staff Regulatory Affairs Specialist for Mako and Enabling Technologies. This remote role provides regulatory leadership across the product lifecycle, partnering with cross-functional teams to support submissions and global market access.

You will develop regulatory strategies, prepare FDA submissions, review documentation, and interact with global authorities while mentoring junior staff in regulatory processes and best practices.