Staff Regulatory Affairs Specialist, Mako and Enabling Technologies

Work Flexibility: Remote

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.

Travel Percentage: NoneStryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Originally posted on Himalayas