Staff Regulatory Affairs Specialist, Mako and Enabling Technologies (Remote)
Stryker
Summary
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.
Job description
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.
Requirements
- 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.
- 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.
Company overview
Stryker is a global leader in medical technology, founded in 1941 by Dr. Homer Stryker and headquartered in Kalamazoo, Michigan. As one of the world's premier medical device companies, Stryker operates across three major business segments: Medical and Surgical Equipment, Orthopaedics and Spine, and Neurotechnology. The company impacts more than 150 million patients annually through its innovative products and services sold in over 75 countries worldwide. With approximately 53,000 employees globally and annual sales of $22.6 billion in 2024, Stryker maintains a strong commitment to research and development, investing $1.5 billion in R&D annually. The company's diverse portfolio includes surgical instruments, orthopedic implants, neurovascular devices, endoscopic systems, and advanced digital healthcare solutions. Stryker is recognized for its Mako robotic-assisted surgery systems and has been consistently ranked as one of Fortune's World's Best Workplaces for eight consecutive years, demonstrating its commitment to corporate culture and employee development.