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

Staff Regulatory Affairs Specialist Mako and Enabling Technologies (Remote)

Join Strykers Ortho Tech Business and support a portfolio that spans robotics navigation imaging software and capital equipment 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

• Bachelors 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 Masters 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: $77700 - $129500 USD Annual
• USN: $95700 - $159500 USD Annual
• US5: $100500 - $167500 USD Annual
• US10: $105300 - $175500 USD Annual
• US15: $110100 - $183400 USD Annual
• US20: $114800 - $191400 USD Annual
• US30: $124400 - $207400 USD Annual