Staff Regulatory Affairs Specialist, Mako and Enabling Technologies (Remote)

Stryker; Mahwah (NJ); Teletrabalho; USD 120 000 - 190 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Regulatory submissions

FDA-regulated industry experience

Cross-functional collaboration

Formação académica

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

Descrição da oferta de emprego

Staff Regulatory Affairs Specialist, Mako and Enabling Technologies (Remote)

Join Stryker’s Ortho Tech Business and support a portfolio that spans robotics, navigation, imaging, software, and capital equipment technologies. In this role, you will provide regulatory leadership throughout the product lifecycle, partnering with cross-functional teams to support global product development, regulatory submissions, market access, and ongoing regulatory compliance across U.S. and international markets.

Work Flexibility

This is a remote position, with a preference for candidates located in the U.S. Eastern Time Zone

What You Will Do

• Develop and execute global regulatory strategies for new products, product changes, and lifecycle management activities.
• Participate in product development teams to ensure U.S., European, and international regulatory requirements are incorporated throughout all development phases.
• Evaluate product classifications, regulatory pathways, and jurisdictional requirements for medical devices and related technologies.
• Author and submit regulatory filings, including FDA submissions, international registrations, and supporting documentation required for product approvals.
• Review quality, preclinical, and clinical documentation to ensure submission readiness and regulatory compliance.
• Partner with global regulatory affiliates to support registrations, market expansions, and post-market regulatory activities.
• Lead interactions with regulatory authorities and notified bodies, including preparation of responses, submissions, and agency communications.
• Review product labeling, marketing materials, and product claims for compliance with applicable regulatory requirements and mentor junior regulatory team members on regulatory processes and best practices.

What You Will Need

Required Qualifications

• Bachelor’s degree in Engineering, Sciences, Regulatory Affairs, or a 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.

Preferred Qualifications

• Regulatory Affairs Certification (RAC) and/or Master’s degree in Regulatory Affairs or a related field.
• Experience supporting Class II and/or Class III medical devices.
• Experience authoring FDA 510(k) submissions.
• Experience interacting directly with regulatory agencies and notified bodies.

United States of America Pay Ranges:

• Puerto Rico: $77,700 - $129,500 USD Annual
• USN: $95,700 - $159,500 USD Annual
• US5: $100,500 - $167,500 USD Annual
• US10: $105,300 - $175,500 USD Annual
• US15: $110,100 - $183,400 USD Annual
• US20: $114,800 - $191,400 USD Annual
• US30: $124,400 - $207,400 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.