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

Stryker Corporation; New Jersey; Remote; USD 78,000 - 191,000; Full time

Job summary

Stryker Corporation in the United States seeks a Remote Staff Regulatory Affairs Specialist to lead regulatory activities across the product lifecycle for Ortho Tech, including robotics, navigation, imaging, software, and capital equipment technologies. The role collaborates with cross-functional teams to ensure regulatory readiness and global compliance.

The position emphasizes development of regulatory strategies, preparation of submissions (FDA and international), and engagement with

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.

Responsibilities

• 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.

Skills

Regulatory affairs

FDA experience

Regulatory submissions

Cross-functional collaboration

Education

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

Job description

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: None

Equal Opportunity Employer Statement

Stryker 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.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Location & Flexibility

Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.